NEEDLE SPINAL S/SU 22GA 1-1/2IN QUINCKE

Additional Manufacturer Narrative

INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED. THE ACTUAL DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER WAS ENTERED INTO THE DATE OF EVENT FIELD.

Description of Event or Problem

MATERIAL # 405161. BATCH # UNKNOWN. VERBATIM: "IN THE PAST WE COULD USE ONE NEEDLE AND SWITCH THE SYRINGE OUT WITH THE THREE INJECTIONS: LIDOCAINE, OMNIPAQUE 300, AND THE STEROID. IT IS BEING REPORTED THAT THEY ARE HAVING ISSUES WITH THE NEEDLE AFTER THE OMNIPAQUE IS INJECTED." CUSTOMER RESPONSE RECEIVED ON (B)(6)2025. 1. COULD YOU PLEASE PROVIDE A FURTHER DESCRIPTION OF THE ISSUE? WHAT KIND OF ISSUE THEY WERE FACED? DIFFICULTY ADMINISTERING STEROID THROUGH 25G BD 1.5¿ NEEDLES FOR STEROID JOINT INJECTIONS. I HAVE BEEN USING THESE NEEDLES FOR GREATER THAN ONE YEAR FOR JOINT INJECTIONS. RECENTLY IN THE LAST MONTH, I WILL GET THE NEEDLE IN PLACE, INJECT OMNIPAQUE 300 THROUGH THE NEEDLE TO CONFIRM CORRECT NEEDLE PLACEMENT AND THEN GO TO INJECT THE STEROID AND WILL BE UNABLE TO PUSH ANYTHING THROUGH THE NEEDLE. I HAVE BEEN DOING THE SAME TECHNIQUE WITH THE SAME EQUIPMENT AND THE SAME MEDICATIONS FOR GREATER THAN ONE YEAR. IT WAS JUST OVER THE PAST MONTH OR SO THAT THIS PROBLEM HAS ARISEN. 2. CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT IN THIS FORMAT MM-DD-YYYY? APPROXIMATELY FROM THE END OF (B)(6) 2024 TO PRESENT DAY. 3. PLEASE SHARE THE LOT NUMBER ASSOCIATED WITH REPORTED ISSUE 3209585. 4. DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT. THIS RESULTS IN A LARGER NEEDLE BEING USED THAN NECESSARY AND A SECOND NEEDLE PUNCTURE TO THE JOINT. 5. ANY PHYSICAL SAMPLE AVAILABLE FOR INVESTIGATION? IF YES, PLEASE PROVIDE THE ADDRESS OF THE FACILITY FOR US TO SHIP THE RETURN LABEL? YES. (B)(6). 6. PLEASE SHARE THE CAPTURED PHOTO OF THE EVENT IF AVAILABLE. N/A.

Description of Event or Problem

NO ADDITIONAL INFORMATION.

Additional Manufacturer Narrative

INVESTIGATION RESULTS: WO (2) 22GA X 1.5¿ UNUSED AND SEALED NEEDLES FOR BATCH NUMBER 3013711 WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. THE SAMPLES WERE SUBMITTED TO INSPECTION FOR VISUAL CHARACTERISTICS POINT QUALITY. NO POINT DAMAGE; INCLUDING HOOKS, SWAGE MARKS, SCRATCHES, INCOMPLETE OR OPEN POINTS, UNSMOOTH GROUND SURFACES, DISCOLORATION OF ANY KIND OR SILVERS; NO PROTRUDERS, AND NO RECEDERS WERE OBSERVED. THE NEEDLES WERE ALSO SUBMITTED FOR TESTING. THE SAMPLES COMPLY WITH THE EXPECTED CHARACTERISTICS; THEREFORE, THE REPORTED FAILURE WAS NOT VERIFIED. A REVIEW OF THE INTERNAL MANUFACTURING DEVICE RECORDS AND RAW MATERIAL HISTORY FILES FOR THE REPORTED LOT NUMBERS WAS PERFORMED AND NO RECORDED QUALITY PROBLEMS OR REJECTIONS TO THIS INCIDENT WERE FOUND. BASED ON THE QUALITY TEAM'S INVESTIGATION, A ROOT CAUSE COULD NOT BE DETERMINED AS THE FAILURE WAS NOT VERIFIED.