CARPUJECT HOLDER

Description of Event or Problem

EVENT VERBATIM [PREFERRED TERM]. THREE THAT SHE CANNOT SEPARATE [DEVICE MECHANICAL ISSUE], THE FIRST ONE SHE TRIED TO OPEN AND THE GLASS BROKE ON IT AND THE NEXT THREE THAT SHE TRY TO OPEN, SHE COULD NOT [DEVICE BREAKAGE], INJECT 4 TO 8 MILLIGRAMS PER MILLILITER INTO THE MUSCLE EVERY 6-8 HOURS [PRODUCT PRESCRIBING ISSUE], NARRATIVE: THIS IS A SPONTANEOUS REPORT RECEIVED FROM A CONSUMER OR OTHER NON-HCP FROM PRODUCT QUALITY GROUP. A 56-YEAR-OLD FEMALE PATIENT RECEIVED HYDROMORPHONE HYDROCHLORIDE (HYDROMORPHONE HYDROCHLORIDE), (LOT NUMBER: LK4292, EXPIRATION DATE: 31MAY2026) AT DAILY (INJECT 4 TO 8 MILLIGRAMS PER MILLILITER INTO THE MUSCLE EVERY 6-8 HOURS(DAILY)) FOR PAIN; CARPUJECT HOLDER (CARPUJECT HOLDER), (LOT NUMBER: UNKNOWN). THE PATIENT'S RELEVANT MEDICAL HISTORY WAS NOT REPORTED. THE PATIENT TOOK CONCOMITANT MEDICATIONS. PAST DRUG HISTORY INCLUDED: CARPUJECT, NOTES: SHE HAD BEEN USING THE 2 MILLIGRAM PER MILLILITER/40 MILLIGRAMS PER 20 MILLILITERS. THE FOLLOWING INFORMATION WAS REPORTED: DEVICE MECHANICAL ISSUE (NON-SERIOUS), DESCRIBED AS "THREE THAT SHE CANNOT SEPARATE"; DEVICE BREAKAGE (NON-SERIOUS), DESCRIBED AS "THE FIRST ONE SHE TRIED TO OPEN AND THE GLASS BROKE ON IT AND THE NEXT THREE THAT SHE TRY TO OPEN, SHE COULD NOT"; PRODUCT PRESCRIBING ISSUE (NON-SERIOUS), DESCRIBED AS "INJECT 4 TO 8 MILLIGRAMS PER MILLILITER INTO THE MUSCLE EVERY 6-8 HOURS". THE ACTION TAKEN FOR HYDROMORPHONE HYDROCHLORIDE AND CARPUJECT HOLDER WAS UNKNOWN. ADDITIONAL INFORMATION: NDC NUMBER OF CARPUJECT HYDROMORPHONE: 0409-1283-03. CONSUMER STATED THERE IS ALL THAT SAYS IT CONTAINS 10 OF, AND THEN IT WAS NDC BUT THEN THERE IS ANOTHER NDC THAT IS THE SAME FIRST NUMBERS BUT INSTEAD OF -03, IT IS -31 (0409-1283-31), THERE IS TWO OF THEM. THE PATIENT WAS AN END USER PATIENT AND FOR YEARS SHE HAD BEEN UTILIZING THE HYDROMORPHONE INJECTABLES AND RECENTLY SHE HAD BEEN USING THE CARPUJECT AND SHE HAD BEEN USING THE 2 MILLIGRAM PER MILLILITER BUT RECENTLY THOSE HAVE BEEN OUT OF STOCK SO SHE HAD BEEN USING THE 1 MILLIGRAM PER MILLILITER AND SHE HAD ISSUES IN THE PAST THAT SHE HAD TAKEN TO HER PHARMACIST AND SHE HAS TOLD HER TO REPORT THEM AND THE PATIENT HAD NOT REPORTED ANYTHING IN THE PAST BECAUSE THEY HAD JUST BEEN A LITTLE ISSUES HERE BUT SHE OPENED A BOX AND SHE HAD ALREADY HAVE FOUR OF THE CARPUJECT. THE FIRST ONE SHE TRIED TO OPEN AND THE GLASS BROKE ON IT AND THE NEXT THREE THAT SHE TRY TO OPEN, SHE COULD NOT. EVEN TRYING EXTREME CAREFULLY, SEPARATE THE PLUNGER PORTION APART FROM THE GLASS CARPUJECT PORTION AND SHE WAS AFRAID THAT THEY ARE GOING TO BREAK. SO, SHE HAVE ONE THAT BROKE AND THREE THAT SHE CANNOT SEPARATE AND SHE DO HAVE 48 BOXES OF THEM. SO, SHE HAVE MANAGED TO UTILIZE SEVERAL BOXES UP WITHOUT HAVING PROBLEMS BUT SHE DO HAVE MANY BOXES REMAINING AND SHE WAS CONCERNED. SHE CLAIMED 48 BOXES FROM THE PHARMACIST, SHE PROBABLY HAVE ABOUT 32 OF THEM LEFT AND SHE HAD NOT HAVE AN ISSUE UNTIL SHE CAME TO THIS BOX AND THE FIRST CARPUJECT SHE PULLED OUT, THE GLASS BROKE AND THEN THE NEXT THREE THAT SHE PULLED OUT, SHE WAS UNABLE TO SEPARATE THE PLUNGER FROM THE GLASS CONTAINER AND SHE TRIED VERY GENTLY TO REMOVE IT BUT SHE WAS WORRIED THAT SHE WOULD BREAK THE GLASS. IT IS 1 MILLILITER PER MILLIGRAM AND SHE USUALLY GET IT IN MUCH HIGHER DOSE BUT THIS IS ALL IT IS AVAILABLE RIGHT NOW. SHE NORMALLY GETS 40 MILLIGRAMS PER 20 MILLILITERS BUT THIS WAS ALL THAT IS AVAILABLE AND IT IS HORRIBLE BUT THE DIRECTIONS ARE, THIS IS 1 MILLILITER PER MILLIGRAM OR 1 MILLIGRAM PER MILLILITER AND THE INJECTION, THE INSTRUCTIONS ARE INJECT 4 TO 8 MILLIGRAMS PER MILLILITER INTO THE MUSCLE EVERY 6-8 HOURS. SHE DID NO MEDICAL INTERVENTION. THERE WAS ONLY ONE LOT WITH 4 CARPUJECT SYRINGES INVOLVED. THE PATIENT IS NOT USING A CARPUJECT HOLDER (AS REPORTED). SHE STATED SHE NORMALLY REMOVES THE WHITE BARBELL (HUB CAP) FROM THE SYRINGE WITH EASE. THE GLASS OF ONE OF THE 4 SYRINGES BROKE WHEN SHE ATTEMPTED TO REMOVE THE HUB CAP. THE OTHER 3 FELT AS THOUGH THEY WERE GOING TO BREAK. SHE STILL HAS THE BROKEN SYRINGE AND AGREED TO SEND PHOTOS OF IT. THE OTHER 3 SYRINGES HAVE BEEN DISCARDED. CONSUMER IS AN EXPERIENCED USER WHO HAS USED THE PRODUCT FOR MANY YEARS AND HAS ALWAYS DONE IT THIS WAY. SHE REMOVES THE HUBCAP AND USES THE GREEN CAP AS A PLUNGER TO MOVE THE PRODUCT DOWN THE TUBE. SHE WITHDRAWS THE PRODUCT USING HER OWN PERSONAL SYRINGE/NEEDLE. CONSUMER ALSO AGREED TO SEND A PHOTO OF A SYRINGE THAT SHE HAS USED WITHOUT ISSUE TO DEMONSTRATE HER PROCESS. ADVISED REPORTER THAT ANY REQUEST FOR REPLACEMENT WOULD HAVE TO OCCUR WITH HER PHARMACY. DUE TO ONLY HAVING ISSUE WITH 4 SYRINGES, CONSUMER IS NOT LOOKING FOR REPLACEMENT. SHE DID MENTION IN THE PAST THAT SHE'S HAD ISSUES WITH 2 OTHER SYRINGES THAT SHE DID NOT REPORT. ONE, IN WHICH THERE WAS NO MEDICATION AND ANOTHER IN WHICH THE MEDICATION LEAKED DOWN PAST THE PLUNGER. LOTS AND SAMPLES ARE NOT AVAILABLE FOR THE PREVIOUS DEFECTIVE SYRINGES. PATIENT ALSO MENTIONED THAT SHE WISHES THE PRODUCT WAS AVAILABLE IN LARGER DOSES. SHE SUFFERS FROM CHRONIC PAIN AND GETS 48 BOXES PER MONTH WHICH AMOUNTS TO HER STICKING HERSELF 16 TIMES PER DAY. IF PRODUCT WAS AVAILABLE IN HIGHER DOSES SHE WOULD NOT HAVE TO STICK HERSELF SO MANY TIMES. WHEN ASKED ABOUT IF A SAMPLE OF THE PRODUCT IS AVAILABLE TO BE RETURNED, CONSUMER STATED, SHE THOUGHT IT IS IF YOU SEND HER A RETURN SHIPPING LABEL BUT SHE NEED MEDICATION. SHE TOOK THIS MEDICATION DAILY AND THAT ONE OF THE FRUSTRATION IS, IT IS REALLY HARD TO GET IT. IT HAS BEEN OUT OF STOCK. SHE WOULD LIKE TO GET IT IN 40 MILLIGRAMS PER 20 MILLILITER OR AT LEAST 2 MILLIGRAM PER 1 MILLILITER. NDC#: REPORTER THINKS IT IS INDIVIDUAL CARPUJECT AND IT SAYS IT CONTAINS 10 OF THOSE AND THEN THE UPC CODE. THE UPC CODE, IT SAYS (01) NEXT TO IT, IT SAYS (B)(6). PACKAGING SEALED AND INTACT: CONSUMER STATED YES AND SHE HAS MULTIPLE BOXES THAT ARE STILL SEALED AND INTACT AND PROBABLY NOT, SHE DOES NOT KNOW IF THIS IS JUST, THESE FOUR OR IF THERE ARE OTHERS IN THIS GROUP OR WHAT IS GOING ON. CAUSALITY FOR "THREE THAT SHE CANNOT SEPARATE" AND "THE FIRST ONE SHE TRIED TO OPEN AND THE GLASS BROKE ON IT AND THE NEXT THREE THAT SHE TRY TO OPEN, SHE COULD NOT" WAS DETERMINED ASSOCIATED TO DEVICE CONSTITUENT OF HYDROMORPHONE HYDROCHLORIDE (MALFUNCTION). CAUSALITY FOR "THREE THAT SHE CANNOT SEPARATE" AND "THE FIRST ONE SHE TRIED TO OPEN AND THE GLASS BROKE ON IT AND THE NEXT THREE THAT SHE TRY TO OPEN, SHE COULD NOT" WAS DETERMINED ASSOCIATED TO CARPUJECT HOLDER (MALFUNCTION). CAUSALITY FOR "INJECT 4 TO 8 MILLIGRAMS PER MILLILITER INTO THE MUSCLE EVERY 6-8 HOURS" WAS DETERMINED NOT ASSOCIATED TO CARPUJECT HOLDER (MALFUNCTION). INVESTIGATION SUMMARY AND CONCLUSION: MANUFACTURE SITE INVESTIGATION: THE COMPLAINT FOR CONTAINER BROKEN/CRACKED DURING PREP/USE IN A CARPUJECT OF HYDROMORPHONE PRODUCT WAS INVESTIGATED. THE INVESTIGATION INCLUDED REVIEWING INCOMING, FILLING, AND VISUAL INSPECTION BATCH RECORDS, DEVIATION INVESTIGATIONS, AND AN ANALYSIS OF THE COMPLAINT HISTORY FOR THE REPORTED LOT AND PRODUCT TYPE. THIS PRODUCT IS FILLED, LABELED, AND PACKAGED BY PIZER. THE FINAL SCOPE WILL REMAIN LOT LK4292 AND FILL LOT LJ2349. NO QUALITY ISSUES WERE IDENTIFIED DURING THE INVESTIGATION THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE COMPLAINT CONDITION. AN ISSUE ESCALATION WAS NOT ISSUED FOR THE CURRENT COMPLAINT. A MEDICAL DEVICE REPORT (MDR) WAS FILED FOR THE COMPLAINT BUT NO OTHER REGULATORY NOTIFICATION, SITE QUALITY REVIEW TEAM (SQRT), OR AREA QUALITY REVIEW TEAM (AQRT)S WERE HELD BECAUSE OF THIS COMPLAINT. PICTURES NOR SAMPLE WERE PROVIDED TO THE MCPHERSON SITE TO FURTHER ANALYZE. THE ROOT CAUSE COULD NOT BE DETERMINED AS MANUFACTURE RELATED AS THE UNIT WAS NOT IDENTIFIED AS BEING BROKEN/CRACKED PRIOR TO INSERTING THE UNIT INTO THE CARPUJECT HOLDER. IT IS SUSPECTED THAT THE END USER WAS NOT USING THE UNIT CORRECTLY. USER ERROR CANNOT BE RULED OUT. PICTURES NOR SAMPLE WERE RECEIVED BY PFIZER MCPHERSON TO FURTHER ANALYZE. THE COMPLAINT FOR BROKEN DURING USED COULD NOT BE CONFIRMED OR ATTRIBUTED TO THE MANUFACTURE OF VENDOR PROCESSES. THE UNIT WAS NOT IDENTIFIED AS BEING BROKEN/CRACKED PRIOR TO THE END USER TRYING TO SEPARATE THE PLUNGER FROM THE GLASS. THE INVESTIGATION DID NOT IDENTIFY ANY ISSUES DURING THE MANUFACTURING PROCESS THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE COMPLAINT CONDITION. PICTURES NOR SAMPLES WERE RECEIVED BY PFIZER MCPHERSON TO FURTHER ANALYZE. USER ERROR CANNOT BE RULED OUT. THE CONTROLS CURRENTLY IN PLACE ARE SUFFICIENT FOR DETECTING AND REJECTING ANY CARPUJECTS SUSPECTED OF HAVING ANY DEFECTS. THE REPORTED DEFECT IS NOT REPRESENTATIVE OF THE QUALITY OF THE BATCH AND REMAINS ACCEPTABLE FOR FURTHER DISTRIBUTION. DEVICE ENGINEERING INVESTIGATION: THIS INVESTIGATION IS BASED ON THE INFORMATION CAPTURED IN THE COMPLAINT DESCRIPTION AND ARGUS REPORT. THE COMPLAINT ISSUE, CARTRIDGE/SYRINGE BARREL BROKEN DURING PREP/USE, WAS REPORTED. THE RISK MANAGEMENT FILE WAS REVIEWED TO CONFIRM THAT THE HAZARD(S) AND HAZARDOUS SITUATION(S) ASSOCIATED WITH THE COMPLAINT ISSUE ARE DOCUMENTED IN THE HAZARD ANALYSIS ((B)(4)), VERSION (5.0). ALL COMPLAINT INVESTIGATIONS ARE TRENDED. THERE IS NO CURRENT TREND ALERT DOCUMENTED. FOLLOW-UP (20DEC2024): THIS IS A SPONTANEOUS FOLLOW-UP REPORT FROM PRODUCT QUALITY GROUP. UPDATED INFORMATION INCLUDED: EVENT AND PRODUCT DETAILS. THE EVENT "INJECT 4 TO 8 MILLIGRAMS PER MILLILITER INTO THE MUSCLE EVERY 6-8 HOURS" UPDATED. FOLLOW-UP (02FEB2025): FOLLOW-UP ATTEMPTS ARE COMPLETED. FOLLOW-UP (05FEB2025): THIS IS A SPONTANEOUS FOLLOW-UP REPORT RECEIVED FROM PRODUCT QUALITY GROUP PROVIDING INVESTIGATION RESULTS. UPDATED INFORMATION INCLUDED: ADDITIONAL PRODUCT INFORMATION AND INVESTIGATION RESULTS. FOLLOW-UP (19FEB2025): THIS IS A SPONTANEOUS FOLLOW-UP REPORT RECEIVED FROM PRODUCT QUALITY GROUP PROVIDING INVESTIGATION RESULTS. UPDATED INFORMATION INCLUDED: INVESTIGATION RESULTS.

Description of Event or Problem

EVENT VERBATIM [PREFERRED TERM] THREE THAT SHE CANNOT SEPARATE [DEVICE MECHANICAL ISSUE], THE FIRST ONE SHE TRIED TO OPEN AND THE GLASS BROKE ON IT AND THE NEXT THREE THAT SHE TRY TO OPEN, SHE COULD NOT [DEVICE BREAKAGE], INJECT 4 TO 8 MILLIGRAMS PER MILLILITER INTO THE MUSCLE EVERY 6-8 HOURS [PRODUCT PRESCRIBING ISSUE], NARRATIVE: THIS IS A SPONTANEOUS REPORT RECEIVED FROM A CONSUMER OR OTHER NON-HCP FROM PRODUCT QUALITY GROUP. A 56-YEAR-OLD FEMALE PATIENT RECEIVED HYDROMORPHONE HYDROCHLORIDE (HYDROMORPHONE HYDROCHLORIDE), (LOT NUMBER: LK4292, EXPIRATION DATE: 31MAY2026) AT DAILY (INJECT 4 TO 8 MILLIGRAMS PER MILLILITER INTO THE MUSCLE EVERY 6-8 HOURS (DAILY)) FOR PAIN; CARPUJECT HOLDER (CARPUJECT HOLDER), (LOT NUMBER: UNKNOWN). THE PATIENT'S RELEVANT MEDICAL HISTORY WAS NOT REPORTED. THE PATIENT TOOK CONCOMITANT MEDICATIONS. PAST DRUG HISTORY INCLUDED: CARPUJECT, NOTES: SHE HAD BEEN USING THE 2 MILLIGRAM PER MILLILITER/40 MILLIGRAMS PER 20 MILLILITERS. THE FOLLOWING INFORMATION WAS REPORTED: DEVICE MECHANICAL ISSUE (NON-SERIOUS), DESCRIBED AS "THREE THAT SHE CANNOT SEPARATE"; DEVICE BREAKAGE (NON-SERIOUS), DESCRIBED AS "THE FIRST ONE SHE TRIED TO OPEN AND THE GLASS BROKE ON IT AND THE NEXT THREE THAT SHE TRY TO OPEN, SHE COULD NOT"; PRODUCT PRESCRIBING ISSUE (NON-SERIOUS), DESCRIBED AS "INJECT 4 TO 8 MILLIGRAMS PER MILLILITER INTO THE MUSCLE EVERY 6-8 HOURS". THE ACTION TAKEN FOR HYDROMORPHONE HYDROCHLORIDE AND CARPUJECT HOLDER WAS UNKNOWN. CAUSALITY FOR "THREE THAT SHE CANNOT SEPARATE" AND "THE FIRST ONE SHE TRIED TO OPEN AND THE GLASS BROKE ON IT AND THE NEXT THREE THAT SHE TRY TO OPEN, SHE COULD NOT" WAS DETERMINED ASSOCIATED TO DEVICE CONSTITUENT OF HYDROMORPHONE HYDROCHLORIDE (MALFUNCTION). CAUSALITY FOR "THREE THAT SHE CANNOT SEPARATE" AND "THE FIRST ONE SHE TRIED TO OPEN AND THE GLASS BROKE ON IT AND THE NEXT THREE THAT SHE TRY TO OPEN, SHE COULD NOT" WAS DETERMINED ASSOCIATED TO CARPUJECT HOLDER (MALFUNCTION). CAUSALITY FOR "INJECT 4 TO 8 MILLIGRAMS PER MILLILITER INTO THE MUSCLE EVERY 6-8 HOURS" WAS DETERMINED NOT ASSOCIATED TO CARPUJECT HOLDER (MALFUNCTION). ADDITIONAL INFORMATION: NDC NUMBER OF CARPUJECT HYDROMORPHONE: 0409-1283-03. CONSUMER STATED THERE IS ALL THAT SAYS IT CONTAINS 10 OF, AND THEN IT WAS NDC BUT THEN THERE IS ANOTHER NDC THAT IS THE SAME FIRST NUMBERS BUT INSTEAD OF -03, IT IS -31 (0409-1283-31), THERE IS TWO OF THEM. THE PATIENT WAS AN END USER PATIENT AND FOR YEARS SHE HAD BEEN UTILIZING THE HYDROMORPHONE INJECTABLES AND RECENTLY SHE HAD BEEN USING THE CARPUJECT AND SHE HAD BEEN USING THE 2 MILLIGRAM PER MILLILITER BUT RECENTLY THOSE HAVE BEEN OUT OF STOCK SO SHE HAD BEEN USING THE 1 MILLIGRAM PER MILLILITER AND SHE HAD ISSUES IN THE PAST THAT SHE HAD TAKEN TO HER PHARMACIST AND SHE HAS TOLD HER TO REPORT THEM AND THE PATIENT HAD NOT REPORTED ANYTHING IN THE PAST BECAUSE THEY HAD JUST BEEN A LITTLE ISSUES HERE BUT SHE OPENED A BOX AND SHE HAD ALREADY HAVE FOUR OF THE CARPUJECT. THE FIRST ONE SHE TRIED TO OPEN AND THE GLASS BROKE ON IT AND THE NEXT THREE THAT SHE TRY TO OPEN, SHE COULD NOT. EVEN TRYING EXTREME CAREFULLY, SEPARATE THE PLUNGER PORTION APART FROM THE GLASS CARPUJECT PORTION AND SHE WAS AFRAID THAT THEY ARE GOING TO BREAK. SO, SHE HAVE ONE THAT BROKE AND THREE THAT SHE CANNOT SEPARATE AND SHE DO HAVE 48 BOXES OF THEM. SO, SHE HAVE MANAGED TO UTILIZE SEVERAL BOXES UP WITHOUT HAVING PROBLEMS BUT SHE DO HAVE MANY BOXES REMAINING AND SHE WAS CONCERNED. SHE CLAIMED 48 BOXES FROM THE PHARMACIST, SHE PROBABLY HAVE ABOUT 32 OF THEM LEFT AND SHE HAD NOT HAVE AN ISSUE UNTIL SHE CAME TO THIS BOX AND THE FIRST CARPUJECT SHE PULLED OUT, THE GLASS BROKE AND THEN THE NEXT THREE THAT SHE PULLED OUT, SHE WAS UNABLE TO SEPARATE THE PLUNGER FROM THE GLASS CONTAINER AND SHE TRIED VERY GENTLY TO REMOVE IT BUT SHE WAS WORRIED THAT SHE WOULD BREAK THE GLASS. IT IS 1 MILLILITER PER MILLIGRAM AND SHE USUALLY GET IT IN MUCH HIGHER DOSE BUT THIS IS ALL IT IS AVAILABLE RIGHT NOW. SHE NORMALLY GETS 40 MILLIGRAMS PER 20 MILLILITERS BUT THIS WAS ALL THAT IS AVAILABLE AND IT IS HORRIBLE BUT THE DIRECTIONS ARE, THIS IS 1 MILLILITER PER MILLIGRAM OR 1 MILLIGRAM PER MILLILITER AND THE INJECTION, THE INSTRUCTIONS ARE INJECT 4 TO 8 MILLIGRAMS PER MILLILITER INTO THE MUSCLE EVERY 6-8 HOURS. SHE DID NOT MEDICAL INTERVENTION. THERE WAS ONLY ONE LOT WITH 4 CARPUJECT SYRINGES INVOLVED. THE PATIENT IS NOT USING A CARPUJECT HOLDER (AS REPORTED). SHE STATED SHE NORMALLY REMOVES THE WHITE BARBELL (HUB CAP) FROM THE SYRINGE WITH EASE. THE GLASS OF ONE OF THE 4 SYRINGES BROKE WHEN SHE ATTEMPTED TO REMOVE THE HUB CAP. THE OTHER 3 FELT AS THOUGH THEY WERE GOING TO BREAK. SHE STILL HAS THE BROKEN SYRINGE AND AGREED TO SEND PHOTOS OF IT. THE OTHER 3 SYRINGES HAVE BEEN DISCARDED. CONSUMER IS AN EXPERIENCED USER WHO HAS USED THE PRODUCT FOR MANY YEARS AND HAS ALWAYS DONE IT THIS WAY. SHE REMOVES THE HUBCAP AND USES THE GREEN CAP AS A PLUNGER TO MOVE THE PRODUCT DOWN THE TUBE. SHE WITHDRAWS THE PRODUCT USING HER OWN PERSONAL SYRINGE/NEEDLE. CONSUMER ALSO AGREED TO SEND A PHOTO OF A SYRINGE THAT SHE HAS USED WITHOUT ISSUE TO DEMONSTRATE HER PROCESS. ADVISED REPORTER THAT ANY REQUEST FOR REPLACEMENT WOULD HAVE TO OCCUR WITH HER PHARMACY. DUE TO ONLY HAVING ISSUE WITH 4 SYRINGES, CONSUMER IS NOT LOOKING FOR REPLACEMENT. SHE DID MENTION IN THE PAST THAT SHE'S HAD ISSUES WITH 2 OTHER SYRINGES THAT SHE DID NOT REPORT. ONE, IN WHICH THERE WAS NO MEDICATION AND ANOTHER IN WHICH THE MEDICATION LEAKED DOWN PAST THE PLUNGER. LOTS AND SAMPLES ARE NOT AVAILABLE FOR THE PREVIOUS DEFECTIVE SYRINGES. PATIENT ALSO MENTIONED THAT SHE WISHES THE PRODUCT WAS AVAILABLE IN LARGER DOSES. SHE SUFFERS FROM CHRONIC PAIN AND GETS 48 BOXES PER MONTH WHICH AMOUNTS TO HER STICKING HERSELF 16 TIMES PER DAY. IF PRODUCT WAS AVAILABLE IN HIGHER DOSES, SHE WOULD NOT HAVE TO STICK HERSELF SO MANY TIMES. WHEN ASKED ABOUT IF A SAMPLE OF THE PRODUCT IS AVAILABLE TO BE RETURNED, CONSUMER STATED, SHE THOUGHT IT IS IF YOU SEND HER A RETURN SHIPPING LABEL BUT SHE NEED MEDICATION. SHE TOOK THIS MEDICATION DAILY AND THAT ONE OF THE FRUSTRATION IS, IT IS REALLY HARD TO GET IT. IT HAS BEEN OUT OF STOCK. SHE WOULD LIKE TO GET IT IN 40 MILLIGRAMS PER 20 MILLILITER OR AT LEAST 2 MILLIGRAM PER 1 MILLILITER. FOLLOW-UP (20DEC2024): THIS IS A SPONTANEOUS FOLLOW-UP REPORT FROM PRODUCT QUALITY GROUP. UPDATED INFORMATION INCLUDED: EVENT AND PRODUCT DETAILS. THE EVENT "INJECT 4 TO 8 MILLIGRAMS PER MILLILITER INTO THE MUSCLE EVERY 6-8 HOURS" UPDATED.

Description of Event or Problem

EVENT VERBATIM [PREFERRED TERM]: THREE THAT SHE CANNOT SEPARATE [DEVICE MECHANICAL ISSUE], THE FIRST ONE SHE TRIED TO OPEN AND THE GLASS BROKE ON IT AND THE NEXT THREE THAT SHE TRY TO OPEN, SHE COULD NOT [DEVICE BREAKAGE], INJECT 4 TO 8 MILLIGRAMS PER MILLILITER INTO THE MUSCLE EVERY 6-8 HOURS [PRODUCT PRESCRIBING ISSUE], NARRATIVE: THIS IS A SPONTANEOUS REPORT RECEIVED FROM A CONSUMER OR OTHER NON HCP FROM PRODUCT QUALITY GROUP. A 56-YEAR-OLD FEMALE PATIENT RECEIVED HYDROMORPHONE HYDROCHLORIDE (HYDROMORPHONE HYDROCHLORIDE), (LOT NUMBER: LK4292, EXPIRATION DATE: 31MAY2026) AT DAILY (INJECT 4 TO 8 MILLIGRAMS PER MILLILITER INTO THE MUSCLE EVERY 6-8 HOURS(DAILY)) FOR PAIN; CARPUJECT HOLDER (CARPUJECT HOLDER), (LOT NUMBER: UNKNOWN). THE PATIENT'S RELEVANT MEDICAL HISTORY WAS NOT REPORTED. THE PATIENT TOOK CONCOMITANT MEDICATIONS. PAST DRUG HISTORY INCLUDED: CARPUJECT, NOTES: SHE HAD BEEN USING THE 2 MILLIGRAM PER MILLILITER/40 MILLIGRAMS PER 20 MILLILITERS. THE FOLLOWING INFORMATION WAS REPORTED: DEVICE MECHANICAL ISSUE (NON-SERIOUS), DESCRIBED AS "THREE THAT SHE CANNOT SEPARATE"; DEVICE BREAKAGE (NON-SERIOUS), DESCRIBED AS "THE FIRST ONE SHE TRIED TO OPEN AND THE GLASS BROKE ON IT AND THE NEXT THREE THAT SHE TRY TO OPEN, SHE COULD NOT"; PRODUCT PRESCRIBING ISSUE (NON-SERIOUS), DESCRIBED AS "INJECT 4 TO 8 MILLIGRAMS PER MILLILITER INTO THE MUSCLE EVERY 6-8 HOURS". THE ACTION TAKEN FOR HYDROMORPHONE HYDROCHLORIDE AND CARPUJECT HOLDER WAS UNKNOWN. ADDITIONAL INFORMATION: NDC NUMBER OF CARPUJECT HYDROMORPHONE: 0409-1283-03. CONSUMER STATED THERE IS ALL THAT SAYS IT CONTAINS 10 OF, AND THEN IT WAS NDC BUT THEN THERE IS ANOTHER NDC THAT IS THE SAME FIRST NUMBERS BUT INSTEAD OF -03, IT IS -31 (0409-1283-31), THERE IS TWO OF THEM. THE PATIENT WAS AN END USER PATIENT AND FOR YEARS SHE HAD BEEN UTILIZING THE HYDROMORPHONE INJECTABLES AND RECENTLY SHE HAD BEEN USING THE CARPUJECT AND SHE HAD BEEN USING THE 2 MILLIGRAM PER MILLILITER BUT RECENTLY THOSE HAVE BEEN OUT OF STOCK SO SHE HAD BEEN USING THE 1 MILLIGRAM PER MILLILITER AND SHE HAD ISSUES IN THE PAST THAT SHE HAD TAKEN TO HER PHARMACIST AND SHE HAS TOLD HER TO REPORT THEM AND THE PATIENT HAD NOT REPORTED ANYTHING IN THE PAST BECAUSE THEY HAD JUST BEEN A LITTLE ISSUES HERE BUT SHE OPENED A BOX AND SHE HAD ALREADY HAVE FOUR OF THE CARPUJECT. THE FIRST ONE SHE TRIED TO OPEN AND THE GLASS BROKE ON IT AND THE NEXT THREE THAT SHE TRY TO OPEN, SHE COULD NOT. EVEN TRYING EXTREME CAREFULLY, SEPARATE THE PLUNGER PORTION APART FROM THE GLASS CARPUJECT PORTION AND SHE WAS AFRAID THAT THEY ARE GOING TO BREAK. SO, SHE HAVE ONE THAT BROKE AND THREE THAT SHE CANNOT SEPARATE AND SHE DO HAVE 48 BOXES OF THEM. SO, SHE HAVE MANAGED TO UTILIZE SEVERAL BOXES UP WITHOUT HAVING PROBLEMS BUT SHE DO HAVE MANY BOXES REMAINING AND SHE WAS CONCERNED. SHE CLAIMED 48 BOXES FROM THE PHARMACIST, SHE PROBABLY HAVE ABOUT 32 OF THEM LEFT AND SHE HAD NOT HAVE AN ISSUE UNTIL SHE CAME TO THIS BOX AND THE FIRST CARPUJECT SHE PULLED OUT, THE GLASS BROKE AND THEN THE NEXT THREE THAT SHE PULLED OUT, SHE WAS UNABLE TO SEPARATE THE PLUNGER FROM THE GLASS CONTAINER AND SHE TRIED VERY GENTLY TO REMOVE IT BUT SHE WAS WORRIED THAT SHE WOULD BREAK THE GLASS. IT IS 1 MILLILITER PER MILLIGRAM AND SHE USUALLY GET IT IN MUCH HIGHER DOSE BUT THIS IS ALL IT IS AVAILABLE RIGHT NOW. SHE NORMALLY GETS 40 MILLIGRAMS PER 20 MILLILITERS BUT THIS WAS ALL THAT IS AVAILABLE AND IT IS HORRIBLE BUT THE DIRECTIONS ARE, THIS IS 1 MILLILITER PER MILLIGRAM OR 1 MILLIGRAM PER MILLILITER AND THE INJECTION, THE INSTRUCTIONS ARE INJECT 4 TO 8 MILLIGRAMS PER MILLILITER INTO THE MUSCLE EVERY 6-8 HOURS. SHE DID NOT MEDICAL INTERVENTION. THERE WAS ONLY ONE LOT WITH 4 CARPUJECT SYRINGES INVOLVED. THE PATIENT IS NOT USING A CARPUJECT HOLDER (AS REPORTED). SHE STATED SHE NORMALLY REMOVES THE WHITE BARBELL (HUB CAP) FROM THE SYRINGE WITH EASE. THE GLASS OF ONE OF THE 4 SYRINGES BROKE WHEN SHE ATTEMPTED TO REMOVE THE HUB CAP. THE OTHER 3 FELT AS THOUGH THEY WERE GOING TO BREAK. SHE STILL HAS THE BROKEN SYRINGE AND AGREED TO SEND PHOTOS OF IT. THE OTHER 3 SYRINGES HAVE BEEN DISCARDED. CONSUMER IS AN EXPERIENCED USER WHO HAS USED THE PRODUCT FOR MANY YEARS AND HAS ALWAYS DONE IT THIS WAY. SHE REMOVES THE HUBCAP AND USES THE GREEN CAP AS A PLUNGER TO MOVE THE PRODUCT DOWN THE TUBE. SHE WITHDRAWS THE PRODUCT USING HER OWN PERSONAL SYRINGE/NEEDLE. CONSUMER ALSO AGREED TO SEND A PHOTO OF A SYRINGE THAT SHE HAS USED WITHOUT ISSUE TO DEMONSTRATE HER PROCESS. ADVISED REPORTER THAT ANY REQUEST FOR REPLACEMENT WOULD HAVE TO OCCUR WITH HER PHARMACY. DUE TO ONLY HAVING ISSUE WITH 4 SYRINGES, CONSUMER IS NOT LOOKING FOR REPLACEMENT. SHE DID MENTION IN THE PAST THAT SHE'S HAD ISSUES WITH 2 OTHER SYRINGES THAT SHE DID NOT REPORT. ONE, IN WHICH THERE WAS NO MEDICATION AND ANOTHER IN WHICH THE MEDICATION LEAKED DOWN PAST THE PLUNGER. LOTS AND SAMPLES ARE NOT AVAILABLE FOR THE PREVIOUS DEFECTIVE SYRINGES. PATIENT ALSO MENTIONED THAT SHE WISHES THE PRODUCT WAS AVAILABLE IN LARGER DOSES. SHE SUFFERS FROM CHRONIC PAIN AND GETS 48 BOXES PER MONTH WHICH AMOUNTS TO HER STICKING HERSELF 16 TIMES PER DAY. IF PRODUCT WAS AVAILABLE IN HIGHER DOSES SHE WOULD NOT HAVE TO STICK HERSELF SO MANY TIMES. WHEN ASKED ABOUT IF A SAMPLE OF THE PRODUCT IS AVAILABLE TO BE RETURNED, CONSUMER STATED, SHE THOUGHT IT IS IF YOU SEND HER A RETURN SHIPPING LABEL BUT SHE NEED MEDICATION. SHE TOOK THIS MEDICATION DAILY AND THAT ONE OF THE FRUSTRATION IS, IT IS REALLY HARD TO GET IT. IT HAS BEEN OUT OF STOCK. SHE WOULD LIKE TO GET IT IN 40 MILLIGRAMS PER 20 MILLILITER OR AT LEAST 2 MILLIGRAM PER 1 MILLILITER. NDC#: REPORTER THINKS IT IS INDIVIDUAL CARPUJECT AND IT SAYS IT CONTAINS 10 OF THOSE AND THEN THE UPC CODE. THE UPC CODE, IT SAYS (01) NEXT TO IT, IT SAYS 10304091283319. PACKAGING SEALED AND INTACT: CONSUMER STATED YES AND SHE HAS MULTIPLE BOXES THAT ARE STILL SEALED AND INTACT AND PROBABLY NOT, SHE DOES NOT KNOW IF THIS IS JUST, THESE FOUR OR IF THERE ARE OTHERS IN THIS GROUP OR WHAT IS GOING ON. CAUSALITY FOR "THREE THAT SHE CANNOT SEPARATE" AND "THE FIRST ONE SHE TRIED TO OPEN AND THE GLASS BROKE ON IT AND THE NEXT THREE THAT SHE TRY TO OPEN, SHE COULD NOT" WAS DETERMINED ASSOCIATED TO DEVICE CONSTITUENT OF HYDROMORPHONE HYDROCHLORIDE (MALFUNCTION). CAUSALITY FOR "THREE THAT SHE CANNOT SEPARATE" AND "THE FIRST ONE SHE TRIED TO OPEN AND THE GLASS BROKE ON IT AND THE NEXT THREE THAT SHE TRY TO OPEN, SHE COULD NOT" WAS DETERMINED ASSOCIATED TO CARPUJECT HOLDER (MALFUNCTION). CAUSALITY FOR "INJECT 4 TO 8 MILLIGRAMS PER MILLILITER INTO THE MUSCLE EVERY 6-8 HOURS" WAS DETERMINED NOT ASSOCIATED TO CARPUJECT HOLDER (MALFUNCTION). INVESTIGATION SUMMARY AND CONCLUSION: MANUFACTURE SITE INVESTIGATION: THE COMPLAINT FOR CONTAINER BROKEN/CRACKED DURING PREP/USE IN A CARPUJECT OF HYDROMORPHONE PRODUCT WAS INVESTIGATED. THE INVESTIGATION INCLUDED REVIEWING INCOMING, FILLING, AND VISUAL INSPECTION BATCH RECORDS, DEVIATION INVESTIGATIONS, AND AN ANALYSIS OF THE COMPLAINT HISTORY FOR THE REPORTED LOT AND PRODUCT TYPE. THIS PRODUCT IS FILLED, LABELED, AND PACKAGED BY PIZER. THE FINAL SCOPE WILL REMAIN LOT LK4292 AND FILL LOT LJ2349. NO QUALITY ISSUES WERE IDENTIFIED DURING THE INVESTIGATION THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE COMPLAINT CONDITION. AN ISSUE ESCALATION WAS NOT ISSUED FOR THE CURRENT COMPLAINT. A MEDICAL DEVICE REPORT (MDR) WAS FILED FOR THE COMPLAINT BUT NO OTHER REGULATORY NOTIFICATION, SITE QUALITY REVIEW TEAM (SQRT), OR AREA QUALITY REVIEW TEAM (AQRT)S WERE HELD BECAUSE OF THIS COMPLAINT. PICTURES NOR SAMPLE WERE PROVIDED TO THE MCPHERSON SITE TO FURTHER ANALYZE. THE ROOT CAUSE COULD NOT BE DETERMINED AS MANUFACTURE RELATED AS THE UNIT WAS NOT IDENTIFIED AS BEING BROKEN/CRACKED PRIOR TO INSERTING THE UNIT INTO THE CARPUJECT HOLDER. IT IS SUSPECTED THAT THE END USER WAS NOT USING THE UNIT CORRECTLY. USER ERROR CANNOT BE RULED OUT. PICTURES NOR SAMPLE WERE RECEIVED BY PFIZER MCPHERSON TO FURTHER ANALYZE. THE COMPLAINT FOR BROKEN DURING USED COULD NOT BE CONFIRMED OR ATTRIBUTED TO THE MANUFACTURE OF VENDOR PROCESSES. THE UNIT WAS NOT IDENTIFIED AS BEING BROKEN/CRACKED PRIOR TO THE END USER TRYING TO SEPARATE THE PLUNGER FROM THE GLASS. THE INVESTIGATION DID NOT IDENTIFY ANY ISSUES DURING THE MANUFACTURING PROCESS THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE COMPLAINT CONDITION. PICTURES NOR SAMPLES WERE RECEIVED BY PFIZER MCPHERSON TO FURTHER ANALYZE. USER ERROR CANNOT BE RULED OUT. THE CONTROLS CURRENTLY IN PLACE ARE SUFFICIENT FOR DETECTING AND REJECTING ANY CARPUJECTS SUSPECTED OF HAVING ANY DEFECTS. THE REPORTED DEFECT IS NOT REPRESENTATIVE OF THE QUALITY OF THE BATCH AND REMAINS ACCEPTABLE FOR FURTHER DISTRIBUTION. DEVICE ENGINEERING INVESTIGATION: THIS INVESTIGATION IS BASED ON THE INFORMATION CAPTURED IN THE COMPLAINT DESCRIPTION AND ARGUS REPORT. THE COMPLAINT ISSUE, CARTRIDGE/SYRINGE BARREL BROKEN DURING PREP/USE, WAS REPORTED. THE RISK MANAGEMENT FILE WAS REVIEWED TO CONFIRM THAT THE HAZARD(S) AND HAZARDOUS SITUATION(S) ASSOCIATED WITH THE COMPLAINT ISSUE ARE DOCUMENTED IN THE HAZARD ANALYSIS (INX100388227), VERSION (5.0). ALL COMPLAINT INVESTIGATIONS ARE TRENDED. THERE IS NO CURRENT TREND ALERT DOCUMENTED. FOLLOW-UP (20DEC2024): THIS IS A SPONTANEOUS FOLLOW-UP REPORT FROM PRODUCT QUALITY GROUP. UPDATED INFORMATION INCLUDED: EVENT AND PRODUCT DETAILS. THE EVENT "INJECT 4 TO 8 MILLIGRAMS PER MILLILITER INTO THE MUSCLE EVERY 6-8 HOURS" UPDATED. FOLLOW-UP (02FEB2025): FOLLOW-UP ATTEMPTS ARE COMPLETED. FOLLOW-UP (05FEB2025): THIS IS A SPONTANEOUS FOLLOW-UP REPORT RECEIVED FROM PRODUCT QUALITY GROUP PROVIDING INVESTIGATION RESULTS. UPDATED INFORMATION INCLUDED: ADDITIONAL PRODUCT INFORMATION AND INVESTIGATION RESULTS.

Description of Event or Problem

EVENT VERBATIM [PREFERRED TERM] INJECT 4 TO 8 MILLIGRAMS PER MILLILITER INTO THE MUSCLE EVERY 6-8 HOURS [PRODUCT PRESCRIBING ISSUE], THREE THAT SHE CANNOT SEPARATE [DEVICE MECHANICAL ISSUE], THE FIRST ONE SHE TRIED TO OPEN AND THE GLASS BROKE ON IT AND THE NEXT THREE THAT SHE TRY TO OPEN, SHE COULD NOT [DEVICE BREAKAGE], IMPROPER USE AT HOME OF A CARPUJECT [DEVICE USE ISSUE], , NARRATIVE: THIS IS A SPONTANEOUS REPORT AND RECEIVED FROM CONSUMER OR OTHER NON HCPS FROM PRODUCT QUALITY GROUP. A 56-YEAR-OLD FEMALE PATIENT RECEIVED HYDROMORPHONE HYDROCHLORIDE (HYDROMORPHONE HYDROCHLORIDE), (LOT NUMBER: LK4292, EXPIRATION DATE: 31MAY2026) AT DAILY (INJECT 4 TO 8 MILLIGRAMS PER MILLILITER INTO THE MUSCLE EVERY 6-8 HOURS(DAILY)) FOR PAIN; CARPUJECT HOLDER (CARPUJECT HOLDER), (LOT NUMBER: UNKNOWN). THE PATIENT'S RELEVANT MEDICAL HISTORY WAS NOT REPORTED. THE PATIENT TOOK CONCOMITANT MEDICATIONS. PAST DRUG HISTORY INCLUDED: CARPUJECT, NOTES: SHE HAD BEEN USING THE 2 MILLIGRAM PER MILLILITER/40 MILLIGRAMS PER 20 MILLILITERS. THE FOLLOWING INFORMATION WAS REPORTED: PRODUCT PRESCRIBING ISSUE (NON-SERIOUS), DESCRIBED AS "INJECT 4 TO 8 MILLIGRAMS PER MILLILITER INTO THE MUSCLE EVERY 6-8 HOURS"; DEVICE MECHANICAL ISSUE (NON-SERIOUS), DESCRIBED AS "THREE THAT SHE CANNOT SEPARATE"; DEVICE BREAKAGE (NON-SERIOUS), DESCRIBED AS "THE FIRST ONE SHE TRIED TO OPEN AND THE GLASS BROKE ON IT AND THE NEXT THREE THAT SHE TRY TO OPEN, SHE COULD NOT"; DEVICE USE ISSUE (NON-SERIOUS), DESCRIBED AS "IMPROPER USE OF DEVICE". THE ACTION TAKEN FOR HYDROMORPHONE HYDROCHLORIDE AND CARPUJECT HOLDER WAS UNKNOWN. ADDITIONAL INFORMATION: NDC NUMBER OF CARPUJECT HYDROMORPHONE: 0409-1283-03. CONSUMER STATED THERE IS ALL THAT SAYS IT CONTAINS 10 OF, AND THEN IT WAS NDC BUT THEN THERE IS ANOTHER NDC THAT IS THE SAME FIRST NUMBERS BUT INSTEAD OF -03, IT IS -31 (0409-1283-31), THERE IS TWO OF THEM. THE PATIENT WAS AN END USER PATIENT AND FOR YEARS SHE HAD BEEN UTILIZING THE HYDROMORPHONE INJECTABLES AND RECENTLY SHE HAD BEEN USING THE CARPUJECT AND SHE HAD BEEN USING THE 2 MILLIGRAM PER MILLILITER BUT RECENTLY THOSE HAVE BEEN OUT OF STOCK SO SHE HAD BEEN USING THE 1 MILLIGRAM PER MILLILITER AND SHE HAD ISSUES IN THE PAST THAT SHE HAD TAKEN TO HER PHARMACIST AND SHE HAS TOLD HER TO REPORT THEM AND THE PATIENT HAD NOT REPORTED ANYTHING IN THE PAST BECAUSE THEY HAD JUST BEEN A LITTLE ISSUES HERE BUT SHE OPENED A BOX AND SHE HAD ALREADY HAVE FOUR OF THE CARPUJECT. THE FIRST ONE SHE TRIED TO OPEN AND THE GLASS BROKE ON IT AND THE NEXT THREE THAT SHE TRY TO OPEN, SHE COULD NOT. EVEN TRYING EXTREME CAREFULLY, SEPARATE THE PLUNGER PORTION APART FROM THE GLASS CARPUJECT PORTION AND SHE WAS AFRAID THAT THEY ARE GOING TO BREAK. SO, SHE HAVE ONE THAT BROKE AND THREE THAT SHE CANNOT SEPARATE AND SHE DO HAVE 48 BOXES OF THEM. SO, SHE HAVE MANAGED TO UTILIZE SEVERAL BOXES UP WITHOUT HAVING PROBLEMS BUT SHE DO HAVE MANY BOXES REMAINING AND SHE WAS CONCERNED. SHE CLAIMED 48 BOXES FROM THE PHARMACIST, SHE PROBABLY HAVE ABOUT 32 OF THEM LEFT AND SHE HAD NOT HAVE AN ISSUE UNTIL SHE CAME TO THIS BOX AND THE FIRST CARPUJECT SHE PULLED OUT, THE GLASS BROKE AND THEN THE NEXT THREE THAT SHE PULLED OUT, SHE WAS UNABLE TO SEPARATE THE PLUNGER FROM THE GLASS CONTAINER AND SHE TRIED VERY GENTLY TO REMOVE IT BUT SHE WAS WORRIED THAT SHE WOULD BREAK THE GLASS. IT IS 1 MILLILITER PER MILLIGRAM AND SHE USUALLY GET IT IN MUCH HIGHER DOSE BUT THIS IS ALL IT IS AVAILABLE RIGHT NOW. SHE NORMALLY GETS 40 MILLIGRAMS PER 20 MILLILITERS BUT THIS WAS ALL THAT IS AVAILABLE AND IT IS HORRIBLE BUT THE DIRECTIONS ARE, THIS IS 1 MILLILITER PER MILLIGRAM OR 1 MILLIGRAM PER MILLILITER AND THE INJECTION, THE INSTRUCTIONS ARE INJECT 4 TO 8 MILLIGRAMS PER MILLILITER INTO THE MUSCLE EVERY 6-8 HOURS. SHE DID NOT MEDICAL INTERVENTION. THERE WAS ONLY ONE LOT WITH 4 CARPUJECT SYRINGES INVOLVED. THE PATIENT IS NOT USING A CARPUJECT HOLDER (AS REPORTED). SHE STATED SHE NORMALLY REMOVES THE WHITE BARBELL (HUB CAP) FROM THE SYRINGE WITH EASE. THE GLASS OF ONE OF THE 4 SYRINGES BROKE WHEN SHE ATTEMPTED TO REMOVE THE HUB CAP. THE OTHER 3 FELT AS THOUGH THEY WERE GOING TO BREAK. SHE STILL HAS THE BROKEN SYRINGE AND AGREED TO SEND PHOTOS OF IT. THE OTHER 3 SYRINGES HAVE BEEN DISCARDED. CONSUMER IS AN EXPERIENCED USER WHO HAS USED THE PRODUCT FOR MANY YEARS AND HAS ALWAYS DONE IT THIS WAY. SHE REMOVES THE HUBCAP AND USES THE GREEN CAP AS A PLUNGER TO MOVE THE PRODUCT DOWN THE TUBE. SHE WITHDRAWS THE PRODUCT USING HER OWN PERSONAL SYRINGE/NEEDLE. CONSUMER ALSO AGREED TO SEND A PHOTO OF A SYRINGE THAT SHE HAS USED WITHOUT ISSUE TO DEMONSTRATE HER PROCESS. ADVISED REPORTER THAT ANY REQUEST FOR REPLACEMENT WOULD HAVE TO OCCUR WITH HER PHARMACY. DUE TO ONLY HAVING ISSUE WITH 4 SYRINGES, CONSUMER IS NOT LOOKING FOR REPLACEMENT. SHE DID MENTION IN THE PAST THAT SHE'S HAD ISSUES WITH 2 OTHER SYRINGES THAT SHE DID NOT REPORT. ONE, IN WHICH THERE WAS NO MEDICATION AND ANOTHER IN WHICH THE MEDICATION LEAKED DOWN PAST THE PLUNGER. LOTS AND SAMPLES ARE NOT AVAILABLE FOR THE PREVIOUS DEFECTIVE SYRINGES. PATIENT ALSO MENTIONED THAT SHE WISHES THE PRODUCT WAS AVAILABLE IN LARGER DOSES. SHE SUFFERS FROM CHRONIC PAIN AND GETS 48 BOXES PER MONTH WHICH AMOUNTS TO HER STICKING HERSELF 16 TIMES PER DAY. IF PRODUCT WAS AVAILABLE IN HIGHER DOSES SHE WOULD NOT HAVE TO STICK HERSELF SO MANY TIMES. WHEN ASKED ABOUT IF A SAMPLE OF THE PRODUCT IS AVAILABLE TO BE RETURNED, CONSUMER STATED, SHE THOUGHT IT IS IF YOU SEND HER A RETURN SHIPPING LABEL BUT SHE NEED MEDICATION. SHE TOOK THIS MEDICATION DAILY AND THAT ONE OF THE FRUSTRATION IS, IT IS REALLY HARD TO GET IT. IT HAS BEEN OUT OF STOCK. SHE WOULD LIKE TO GET IT IN 40 MILLIGRAMS PER 20 MILLILITER OR AT LEAST 2 MILLIGRAM PER 1 MILLILITER. NDC#: REPORTER THINKS IT IS INDIVIDUAL CARPUJECT AND IT SAYS IT CONTAINS 10 OF THOSE AND THEN THE UPC CODE. THE UPC CODE, IT SAYS (01) NEXT TO IT, IT SAYS (B)(4). PACKAGING SEALED AND INTACT: CONSUMER STATED YES AND SHE HAS MULTIPLE BOXES THAT ARE STILL SEALED AND INTACT AND PROBABLY NOT, SHE DOES NOT KNOW IF THIS IS JUST, THESE FOUR OR IF THERE ARE OTHERS IN THIS GROUP OR WHAT IS GOING ON. AS OF (B)(6) 2025, IT WAS REPORTED THAT THERE WAS IMPROPER USE AT HOME OF A CARPUJECT. THE IMPROPER USE LEAD TO A BROKEN VIAL. CAUSALITY FOR "THREE THAT SHE CANNOT SEPARATE" AND "THE FIRST ONE SHE TRIED TO OPEN AND THE GLASS BROKE ON IT AND THE NEXT THREE THAT SHE TRY TO OPEN, SHE COULD NOT" WAS DETERMINED ASSOCIATED TO DEVICE CONSTITUENT OF HYDROMORPHONE HYDROCHLORIDE (MALFUNCTION). CAUSALITY FOR "THREE THAT SHE CANNOT SEPARATE" AND "THE FIRST ONE SHE TRIED TO OPEN AND THE GLASS BROKE ON IT AND THE NEXT THREE THAT SHE TRY TO OPEN, SHE COULD NOT" WAS DETERMINED ASSOCIATED TO CARPUJECT HOLDER (MALFUNCTION). CAUSALITY FOR "INJECT 4 TO 8 MILLIGRAMS PER MILLILITER INTO THE MUSCLE EVERY 6-8 HOURS" WAS DETERMINED NOT ASSOCIATED TO CARPUJECT HOLDER (MALFUNCTION). INVESTIGATION SUMMARY AND CONCLUSION: MANUFACTURE SITE INVESTIGATION: THE COMPLAINT FOR CONTAINER BROKEN/CRACKED DURING PREP/USE IN A CARPUJECT OF HYDROMORPHONE PRODUCT WAS INVESTIGATED. THE INVESTIGATION INCLUDED REVIEWING INCOMING, FILLING, AND VISUAL INSPECTION BATCH RECORDS, DEVIATION INVESTIGATIONS, AND AN ANALYSIS OF THE COMPLAINT HISTORY FOR THE REPORTED LOT AND PRODUCT TYPE. THIS PRODUCT IS FILLED, LABELED, AND PACKAGED BY PIZER. THE FINAL SCOPE WILL REMAIN LOT LK4292 AND FILL LOT LJ2349. NO QUALITY ISSUES WERE IDENTIFIED DURING THE INVESTIGATION THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE COMPLAINT CONDITION. AN ISSUE ESCALATION WAS NOT ISSUED FOR THE CURRENT COMPLAINT. A MEDICAL DEVICE REPORT (MDR) WAS FILED FOR THE COMPLAINT BUT NO OTHER REGULATORY NOTIFICATION, SITE QUALITY REVIEW TEAM (SQRT), OR AREA QUALITY REVIEW TEAM (AQRT)S WERE HELD BECAUSE OF THIS COMPLAINT. PICTURES NOR SAMPLE WERE PROVIDED TO THE MCPHERSON SITE TO FURTHER ANALYZE. THE ROOT CAUSE COULD NOT BE DETERMINED AS MANUFACTURE RELATED AS THE UNIT WAS NOT IDENTIFIED AS BEING BROKEN/CRACKED PRIOR TO INSERTING THE UNIT INTO THE CARPUJECT HOLDER. IT IS SUSPECTED THAT THE END USER WAS NOT USING THE UNIT CORRECTLY. USER ERROR CANNOT BE RULED OUT. PICTURES NOR SAMPLE WERE RECEIVED BY PFIZER MCPHERSON TO FURTHER ANALYZE. THE COMPLAINT FOR BROKEN DURING USED COULD NOT BE CONFIRMED OR ATTRIBUTED TO THE MANUFACTURE OF VENDOR PROCESSES. THE UNIT WAS NOT IDENTIFIED AS BEING BROKEN/CRACKED PRIOR TO THE END USER TRYING TO SEPARATE THE PLUNGER FROM THE GLASS. THE INVESTIGATION DID NOT IDENTIFY ANY ISSUES DURING THE MANUFACTURING PROCESS THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE COMPLAINT CONDITION. PICTURES NOR SAMPLES WERE RECEIVED BY PFIZER MCPHERSON TO FURTHER ANALYZE. USER ERROR CANNOT BE RULED OUT. THE CONTROLS CURRENTLY IN PLACE ARE SUFFICIENT FOR DETECTING AND REJECTING ANY CARPUJECTS SUSPECTED OF HAVING ANY DEFECTS. THE REPORTED DEFECT IS NOT REPRESENTATIVE OF THE QUALITY OF THE BATCH AND REMAINS ACCEPTABLE FOR FURTHER DISTRIBUTION. DEVICE ENGINEERING INVESTIGATION: THIS INVESTIGATION IS BASED ON THE INFORMATION CAPTURED IN THE COMPLAINT DESCRIPTION AND ARGUS REPORT. THE COMPLAINT ISSUE, CARTRIDGE/SYRINGE BARREL BROKEN DURING PREP/USE, WAS REPORTED. THE RISK MANAGEMENT FILE WAS REVIEWED TO CONFIRM THAT THE HAZARD(S) AND HAZARDOUS SITUATION(S) ASSOCIATED WITH THE COMPLAINT ISSUE ARE DOCUMENTED IN THE HAZARD ANALYSIS (INX100388227), VERSION (5.0). ALL COMPLAINT INVESTIGATIONS ARE TRENDED. THERE IS NO CURRENT TREND ALERT DOCUMENTED. FOLLOW-UP (20DEC2024): THIS IS A SPONTANEOUS FOLLOW-UP REPORT FROM PRODUCT QUALITY GROUP. UPDATED INFORMATION INCLUDED: EVENT AND PRODUCT DETAILS. THE EVENT "INJECT 4 TO 8 MILLIGRAMS PER MILLILITER INTO THE MUSCLE EVERY 6-8 HOURS" UPDATED. FOLLOW-UP (02FEB2025): FOLLOW-UP ATTEMPTS ARE COMPLETED. FOLLOW-UP (05FEB2025): THIS IS A SPONTANEOUS FOLLOW-UP REPORT RECEIVED FROM PRODUCT QUALITY GROUP PROVIDING INVESTIGATION RESULTS. UPDATED INFORMATION INCLUDED: ADDITIONAL PRODUCT INFORMATION AND INVESTIGATION RESULTS. FOLLOW-UP (19FEB2025): THIS IS A SPONTANEOUS FOLLOW-UP REPORT RECEIVED FROM PRODUCT QUALITY GROUP PROVIDING INVESTIGATION RESULTS. UPDATED INFORMATION INCLUDED: INVESTIGATION RESULTS. FOLLOW-UP (27FEB2025): THIS IS A FOLLOW-UP REPORT COMBINING INFORMATION FROM DUPLICATE REPORTS 202500041787 AND 202400325937. THE CURRENT AND ALL SUBSEQUENT INFORMATION WILL BE REPORTED UNDER MANUFACTURER REPORT NUMBER 202400325937. THE NEW INFORMATION REPORTED FROM A CONSUMER OR OTHER NON-HCP INCLUDES: NEW REPORTERS AND NEW EVENT (IMPROPER USE AT HOME OF A CARPUJECT) ADDED.

Description of Event or Problem

EVENT VERBATIM [PREFERRED TERM]. THREE THAT SHE CANNOT SEPARATE [DEVICE MECHANICAL ISSUE], THE FIRST ONE SHE TRIED TO OPEN AND THE GLASS BROKE ON IT AND THE NEXT THREE THAT SHE TRY TO OPEN, SHE COULD NOT [DEVICE BREAKAGE], INJECT 4 TO 8 MILLIGRAMS PER MILLILITER INTO THE MUSCLE EVERY 6-8 HOURS [PRODUCT PRESCRIBING ISSUE], NARRATIVE: THIS IS A SPONTANEOUS REPORT RECEIVED FROM A CONSUMER OR OTHER NON-HCP FROM PRODUCT QUALITY GROUP. A 56-YEAR-OLD FEMALE PATIENT RECEIVED HYDROMORPHONE HYDROCHLORIDE (HYDROMORPHONE HYDROCHLORIDE), (LOT NUMBER: LK4292, EXPIRATION DATE: 31MAY2026) AT DAILY (INJECT 4 TO 8 MILLIGRAMS PER MILLILITER INTO THE MUSCLE EVERY 6-8 HOURS(DAILY)) FOR PAIN; CARPUJECT HOLDER (CARPUJECT HOLDER), (LOT NUMBER: UNKNOWN). THE PATIENT'S RELEVANT MEDICAL HISTORY WAS NOT REPORTED. THE PATIENT TOOK CONCOMITANT MEDICATIONS. PAST DRUG HISTORY INCLUDED: CARPUJECT, NOTES: SHE HAD BEEN USING THE 2 MILLIGRAM PER MILLILITER/40 MILLIGRAMS PER 20 MILLILITERS. THE FOLLOWING INFORMATION WAS REPORTED: DEVICE MECHANICAL ISSUE (NON-SERIOUS), DESCRIBED AS "THREE THAT SHE CANNOT SEPARATE"; DEVICE BREAKAGE (NON-SERIOUS), DESCRIBED AS "THE FIRST ONE SHE TRIED TO OPEN AND THE GLASS BROKE ON IT AND THE NEXT THREE THAT SHE TRY TO OPEN, SHE COULD NOT"; PRODUCT PRESCRIBING ISSUE (NON-SERIOUS), DESCRIBED AS "INJECT 4 TO 8 MILLIGRAMS PER MILLILITER INTO THE MUSCLE EVERY 6-8 HOURS". THE ACTION TAKEN FOR HYDROMORPHONE HYDROCHLORIDE AND CARPUJECT HOLDER WAS UNKNOWN. CAUSALITY FOR "THREE THAT SHE CANNOT SEPARATE" AND "THE FIRST ONE SHE TRIED TO OPEN AND THE GLASS BROKE ON IT AND THE NEXT THREE THAT SHE TRY TO OPEN, SHE COULD NOT" WAS DETERMINED ASSOCIATED TO DEVICE CONSTITUENT OF HYDROMORPHONE HYDROCHLORIDE (MALFUNCTION). CAUSALITY FOR "THREE THAT SHE CANNOT SEPARATE" AND "THE FIRST ONE SHE TRIED TO OPEN AND THE GLASS BROKE ON IT AND THE NEXT THREE THAT SHE TRY TO OPEN, SHE COULD NOT" WAS DETERMINED ASSOCIATED TO CARPUJECT HOLDER (MALFUNCTION). CAUSALITY FOR "INJECT 4 TO 8 MILLIGRAMS PER MILLILITER INTO THE MUSCLE EVERY 6-8 HOURS" WAS DETERMINED NOT ASSOCIATED TO CARPUJECT HOLDER (MALFUNCTION). ADDITIONAL INFORMATION: NDC NUMBER OF CARPUJECT HYDROMORPHONE: 0409-1283-03. CONSUMER STATED THERE IS ALL THAT SAYS IT CONTAINS 10 OF, AND THEN IT WAS NDC BUT THEN THERE IS ANOTHER NDC THAT IS THE SAME FIRST NUMBERS BUT INSTEAD OF -03, IT IS -31 (0409-1283-31), THERE IS TWO OF THEM. THE PATIENT WAS AN END USER PATIENT AND FOR YEARS SHE HAD BEEN UTILIZING THE HYDROMORPHONE INJECTABLES AND RECENTLY SHE HAD BEEN USING THE CARPUJECT AND SHE HAD BEEN USING THE 2 MILLIGRAM PER MILLILITER BUT RECENTLY THOSE HAVE BEEN OUT OF STOCK SO SHE HAD BEEN USING THE 1 MILLIGRAM PER MILLILITER AND SHE HAD ISSUES IN THE PAST THAT SHE HAD TAKEN TO HER PHARMACIST AND SHE HAS TOLD HER TO REPORT THEM AND THE PATIENT HAD NOT REPORTED ANYTHING IN THE PAST BECAUSE THEY HAD JUST BEEN A LITTLE ISSUES HERE BUT SHE OPENED A BOX AND SHE HAD ALREADY HAVE FOUR OF THE CARPUJECT. THE FIRST ONE SHE TRIED TO OPEN AND THE GLASS BROKE ON IT AND THE NEXT THREE THAT SHE TRY TO OPEN, SHE COULD NOT. EVEN TRYING EXTREME CAREFULLY, SEPARATE THE PLUNGER PORTION APART FROM THE GLASS CARPUJECT PORTION AND SHE WAS AFRAID THAT THEY ARE GOING TO BREAK. SO, SHE HAVE ONE THAT BROKE AND THREE THAT SHE CANNOT SEPARATE AND SHE DO HAVE 48 BOXES OF THEM. SO, SHE HAVE MANAGED TO UTILIZE SEVERAL BOXES UP WITHOUT HAVING PROBLEMS BUT SHE DO HAVE MANY BOXES REMAINING AND SHE WAS CONCERNED. SHE CLAIMED 48 BOXES FROM THE PHARMACIST, SHE PROBABLY HAVE ABOUT 32 OF THEM LEFT AND SHE HAD NOT HAVE AN ISSUE UNTIL SHE CAME TO THIS BOX AND THE FIRST CARPUJECT SHE PULLED OUT, THE GLASS BROKE AND THEN THE NEXT THREE THAT SHE PULLED OUT, SHE WAS UNABLE TO SEPARATE THE PLUNGER FROM THE GLASS CONTAINER AND SHE TRIED VERY GENTLY TO REMOVE IT BUT SHE WAS WORRIED THAT SHE WOULD BREAK THE GLASS. IT IS 1 MILLILITER PER MILLIGRAM AND SHE USUALLY GET IT IN MUCH HIGHER DOSE BUT THIS IS ALL IT IS AVAILABLE RIGHT NOW. SHE NORMALLY GETS 40 MILLIGRAMS PER 20 MILLILITERS BUT THIS WAS ALL THAT IS AVAILABLE AND IT IS HORRIBLE BUT THE DIRECTIONS ARE, THIS IS 1 MILLILITER PER MILLIGRAM OR 1 MILLIGRAM PER MILLILITER AND THE INJECTION, THE INSTRUCTIONS ARE INJECT 4 TO 8 MILLIGRAMS PER MILLILITER INTO THE MUSCLE EVERY 6-8 HOURS. SHE DID NOT MEDICAL INTERVENTION. THERE WAS ONLY ONE LOT WITH 4 CARPUJECT SYRINGES INVOLVED. THE PATIENT IS NOT USING A CARPUJECT HOLDER (AS REPORTED). SHE STATED SHE NORMALLY REMOVES THE WHITE BARBELL (HUB CAP) FROM THE SYRINGE WITH EASE. THE GLASS OF ONE OF THE 4 SYRINGES BROKE WHEN SHE ATTEMPTED TO REMOVE THE HUB CAP. THE OTHER 3 FELT AS THOUGH THEY WERE GOING TO BREAK. SHE STILL HAS THE BROKEN SYRINGE AND AGREED TO SEND PHOTOS OF IT. THE OTHER 3 SYRINGES HAVE BEEN DISCARDED. CONSUMER IS AN EXPERIENCED USER WHO HAS USED THE PRODUCT FOR MANY YEARS AND HAS ALWAYS DONE IT THIS WAY. SHE REMOVES THE HUBCAP AND USES THE GREEN CAP AS A PLUNGER TO MOVE THE PRODUCT DOWN THE TUBE. SHE WITHDRAWS THE PRODUCT USING HER OWN PERSONAL SYRINGE/NEEDLE. CONSUMER ALSO AGREED TO SEND A PHOTO OF A SYRINGE THAT SHE HAS USED WITHOUT ISSUE TO DEMONSTRATE HER PROCESS. ADVISED REPORTER THAT ANY REQUEST FOR REPLACEMENT WOULD HAVE TO OCCUR WITH HER PHARMACY. DUE TO ONLY HAVING ISSUE WITH 4 SYRINGES, CONSUMER IS NOT LOOKING FOR REPLACEMENT. SHE DID MENTION IN THE PAST THAT SHE'S HAD ISSUES WITH 2 OTHER SYRINGES THAT SHE DID NOT REPORT. ONE, IN WHICH THERE WAS NO MEDICATION AND ANOTHER IN WHICH THE MEDICATION LEAKED DOWN PAST THE PLUNGER. LOTS AND SAMPLES ARE NOT AVAILABLE FOR THE PREVIOUS DEFECTIVE SYRINGES. PATIENT ALSO MENTIONED THAT SHE WISHES THE PRODUCT WAS AVAILABLE IN LARGER DOSES. SHE SUFFERS FROM CHRONIC PAIN AND GETS 48 BOXES PER MONTH WHICH AMOUNTS TO HER STICKING HERSELF 16 TIMES PER DAY. IF PRODUCT WAS AVAILABLE IN HIGHER DOSES, SHE WOULD NOT HAVE TO STICK HERSELF SO MANY TIMES. WHEN ASKED ABOUT IF A SAMPLE OF THE PRODUCT IS AVAILABLE TO BE RETURNED, CONSUMER STATED, SHE THOUGHT IT IS IF YOU SEND HER A RETURN SHIPPING LABEL BUT SHE NEED MEDICATION. SHE TOOK THIS MEDICATION DAILY AND THAT ONE OF THE FRUSTRATION IS, IT IS REALLY HARD TO GET IT. IT HAS BEEN OUT OF STOCK. SHE WOULD LIKE TO GET IT IN 40 MILLIGRAMS PER 20 MILLILITER OR AT LEAST 2 MILLIGRAM PER 1 MILLILITER. FOLLOW-UP (20DEC2024): THIS IS A SPONTANEOUS FOLLOW-UP REPORT FROM PRODUCT QUALITY GROUP. UPDATED INFORMATION INCLUDED: EVENT AND PRODUCT DETAILS. THE EVENT "INJECT 4 TO 8 MILLIGRAMS PER MILLILITER INTO THE MUSCLE EVERY 6-8 HOURS" UPDATED.