BACLOFEN

Additional Manufacturer Narrative

THIS IS DEFAULT TEXT CONFIGURED FOR BLOCK H10.

Description of Event or Problem

NO AIR COULD BE PASSED THROUGH THE ATTACHED TUBING, SUGGESTING THE BLOCKAGE HAD TO DEAL WITH THE TUBING [DEVICE OCCLUSION]. NO ADVERSE EVENT [NO ADVERSE EVENT]. CASE NARRATIVE: THIS INITIAL SPONTANEOUS REPORT CONCERNS EVENTS OF DEVICE OCCLUSION AND NO ADVERSE EVENT IN A MALE PATIENT (AGE AND RACE WERE NOT REPORTED) FROM THE UNITED STATES. THE PATIENT'S AGE AT THE TIME OF EVENT EXPERIENCE WAS NOT REPORTED. ON 07-JAN-2026, AMNEAL PHARMACEUTICALS RECEIVED INFORMATION FROM A CERTIFIED PHYSICIAN ASSISTANT VIA AN EMAIL CONCERNING THE ABOVE-MENTIONED EVENT EXPERIENCED WHILE ON LIORESAL (BACLOFEN) INJECTION. ADDITIONAL SIGNIFICANT INFORMATION (#1) WAS RECEIVED ON 16-JAN-2026 FROM THE CERTIFIED PHYSICIAN ASSISTANT VIA A TELEPHONE CALL. NEW INFORMATION INCLUDED PRODUCT DETAILS (STRENGTH, NDC, RECEIVED DATE) AND NARRATIVE WAS UPDATED. THE PATIENT WAS BEING TREATED WITH LIORESAL INJECTION, 10 MG/5 ML VIA INTRATHECAL ROUTE (DOSE, FREQUENCY, AND THERAPY DATES WERE NOT REPORTED) (NDC: 70121-2505-2, LOT NO: 8325301 AND EXP DATE: 30-APR-2027) FOR AN UNKNOWN INDICATION. THE PATIENT IS A WHEELCHAIR USER. HISTORY OF PROCEDURE INCLUDED MEDICAL DEVICE IMPLANTATION. CONCURRENT CONDITIONS, CO-SUSPECT MEDICATION, MEDICAL HISTORY, HISTORY OF PROCEDURES, CONCOMITANT MEDICATION, ALLERGIES, SMOKING, ALCOHOL CONSUMPTION, RECREATIONAL DRUG USE, AND LABORATORY TEST USE WERE NOT REPORTED. ON 23-DEC-2025, THE HEALTH CARE PROVIDER RECEIVED THE SEALED MEDICATION KIT AND STATED THAT ON AN UNKNOWN DATE WHILE USING IT, HE OBSERVED THAT THE TUBE WAS NOT ALLOWING ANYTHING TO PASS THROUGH IT AND THEY WERE UNABLE TO PULL THE NEEDLE. THE PATIENT WAS POSITIONED RECLINED BACK IN HIS WHEELCHAIR, WITH THE ARM OF THE WHEELCHAIR RAISED FOR BETTER ACCESS TO THE PUMP AND TO CREATE AN ADEQUATE STERILE FIELD. THE PUMP SITE WAS THOROUGHLY CLEANED WITH ALCOHOL AND BETADINE. THE SITE WAS ALLOWED TO DRY FOR 3 MINUTES. USING STERILE GLOVES, A STERILE DRAPE WAS PLACED, EXPOSING THE PUMP SITE. A 22-GAUGE NEEDLE WAS ASSEMBLED TO THE EXTENSION SET AND EMPTY SYRINGE THAT CAME WITH THE REFILL KIT. THE CLAMP WAS CLOSED ON THE EXTENSION SET. THE STERILE REFILL TEMPLATE WAS ALIGNED WITH THE PUMP EDGES. A 22-GAUGE NEEDLE WAS INSERTED PERPENDICULAR TO THE PUMP SURFACE, THROUGH THE CENTER OF THE TEMPLATE, IN THE CENTER OF THE RESERVOIR PORT. THE NEEDLE EASILY PASSED THROUGH THE SILICONE SEPTUM AND HIT THE METAL BOTTOM OF THE RESERVOIR PORT. THE CLAMP WAS OPENED; HOWEVER, NO FLUID WAS EXTRACTED ON THE INITIAL ATTEMPT, AND THE SYRINGE PLUNGER WAS UNABLE TO BE DRAWN BACK DUE TO PRESSURE. THE NEEDLE WAS REPOSITIONED INSIDE THE RESERVOIR PORT IN CASE IT HAD BEEN BLOCKED, AND ONCE AGAIN AN ATTEMPT WAS MADE TO DRAW OUT THE FLUID, AND ONCE AGAIN NO FLUID AND THE SYRINGE PLUNGER COULD NOT BE DRAWN BACK DUE TO PRESSURE. THE SYRINGE WAS DETACHED AND CHECKED FOR BLOCKAGE, BUT ONCE DISCONNECTED FROM THE TUBE IT WAS ABLE TO MOVE FREELY. THE NEEDLE WAS REMOVED AND CHECKED FOR BLOCKAGE, AND FLUID COULD BE SEEN IN THE NEEDLE TIP BUT WAS EASILY CLEARED, AND ONCE AGAIN NO BLOCKAGE WAS FOUND. THE TUBING WAS REATTACHED TO THE SYRINGE WITHOUT THE NEEDLE AND TESTED BY TRYING TO PUSH AIR THROUGH. NO AIR COULD BE PASSED THROUGH THE ATTACHED TUBING, SUGGESTING THE BLOCKAGE HAD TO DO WITH THE TUBING. THE TUBING WAS INSPECTED AND FOUND TO BE FREE OF KINKS OR OTHER OBVIOUS SIGNS OF BLOCKAGE. AFTER THE PROCEDURE, AN ATTEMPT WAS MADE TO PASS WATER THROUGH BOTH OPENINGS OF THE TUBE WITH NO WATER BEING ABLE TO PASS THROUGH THE SYRINGE CONNECTION SIDE OF THE TUBING. THE NURSE WAS ABLE TO PROVIDE NEW STERILE TUBING FROM ANOTHER KIT AND ANOTHER ATTEMPT WAS MADE. A 22-GAUGE NEEDLE WAS ASSEMBLED TO THE EXTENSION SET AND EMPTY SYRINGE THAT CAME WITH THE REFILL KIT. THE CLAMP WAS CLOSED ON THE EXTENSION SET. THE STERILE REFILL TEMPLATE WAS ALIGNED WITH THE PUMP EDGES. A 22-GAUGE NEEDLE WAS INSERTED PERPENDICULAR TO THE PUMP SURFACE, THROUGH THE CENTER OF THE TEMPLATE, IN THE CENTER OF THE RESERVOIR PORT. THE NEEDLE EASILY PASSED THROUGH THE SILICONE SEPTUM AND HIT THE METAL BOTTOM OF THE RESERVOIR PORT. THE FLUID WITHDRAWN WAS CLEAR, WITHOUT EVIDENCE OF BLOOD. THE REMAINDER OF THE PROCEDURE WAS ABLE TO BE COMPLETED WITHOUT FURTHER COMPLICATIONS. LAST ACTION TAKEN WITH LIORESAL (BACLOFEN) IN RELATION TO DEVICE OCCLUSION WAS NOT APPLICABLE. DE-CHALLENGE AND RE-CHALLENGE WERE NOT APPLICABLE. THE OUTCOME OF THE DEVICE OCCLUSION EVENT WAS UNKNOWN. THE REPORTER ASSESSED THE CAUSALITY OF THE EVENT DEVICE OCCLUSION AS RELATED TO LIORESAL (BACLOFEN). THIS CASE WAS CONSIDERED NON-SERIOUS. THE REPORTABILITY OF THIS CASE WAS PERIODIC. ON 26-FEB-2026, THE CASE WAS RE-EVALUATED AND RECLASSIFIED AS A SERIOUS, EXPEDITED 30-DAY MALFUNCTION REPORT. THIS REASSESSMENT WAS PROMPTED BY THE RECEIPT OF TWO ADDITIONAL RELATED COMPLAINTS ¿ 2026 AMRX 00746 ON 17-FEB-2026 AND 2026 AMRX 00828 ON 25-FEB-2026. IN LIGHT OF THIS TREND OF MULTIPLE MALFUNCTION COMPLAINTS, THE CASE WAS UPGRADED TO A 30-DAY REPORT. LAST ACTION TAKEN WITH LIORESAL (BACLOFEN) IN RELATION TO DEVICE OCCLUSION WAS NOT APPLICABLE. DE-CHALLENGE AND RE-CHALLENGE WERE NOT APPLICABLE. THE OUTCOME OF THE DEVICE OCCLUSION EVENT WAS UNKNOWN. THIS CASE WAS CONSIDERED SERIOUS. THE REPORTABILITY OF THIS CASE WAS EXPEDITED. THIS SIGNIFICANT FOLLOW UP (#2) INFORMATION RECEIVED ON 14-APR-2026. NEW INFORMATION RECEIVED INCLUDES INVESTIGATION REPORT, ATTACHED WITH THIS CASE. AS PART OF THE INVESTIGATION, THREE (3) PHOTOGRAPHS OF THE PRODUCT AND ONE (1) USED, UNCONTAMINATED SAMPLE WERE PROVIDED. THE SAMPLE AND PHOTOGRAPHS WERE VISUALLY AND PHYSICALLY EVALUATED. THE IMAGES DOCUMENTED THE OVERALL DEVICE, INCLUDING AN IMAGE OF THE INTERNAL PORTION OF THE MALE LUER. PHYSICAL OCCLUSION TESTING WAS PERFORMED ON THE RETURNED SAMPLE AND FAILED. DURING EVALUATION, EXCESS SOLVENT WAS OBSERVED IN THE BONDED JOINT BETWEEN THE TUBING AND THE MALE LUER, CONFIRMING THE PRESENCE OF A PRODUCT DEFECT. A REVIEW OF THE DISCREPANCY MANAGEMENT SYSTEM (DSMS) DATABASE FOR THE REPORTED LOT NUMBER IDENTIFIED NO ABNORMALITIES OR NONCONFORMANCES DURING MANUFACTURING OR FINAL PRODUCT INSPECTION. THE ROOT CAUSE OF THE DEFECT WAS DETERMINED TO BE OPERATOR OVERSIGHT DURING THE MANUAL ASSEMBLY PROCESS, RESULTING IN UNINTENDED APPLICATION OF EXCESS SOLVENT. ALTHOUGH OPERATORS ARE TRAINED AND QUALIFIED, THE MANUALLY ASSEMBLED NATURE OF THE PROCESS RELIES HEAVILY ON INDIVIDUAL ATTENTION TO DETAIL. THE INCIDENT INFORMATION WAS FORWARDED TO THE MANUFACTURING DEPARTMENT TO INCREASE AWARENESS AND HAS BEEN INCLUDED IN ONGOING TREND ANALYSIS OF THE PRODUCT LINE. THE COMPLAINT WILL BE RETAINED FOR REFERENCE, AND SIMILAR REPORTS WILL CONTINUE TO BE MONITORED. LAST ACTION TAKEN WITH LIORESAL (BACLOFEN) IN RELATION TO DEVICE OCCLUSION WAS NOT APPLICABLE. DE-CHALLENGE AND RE-CHALLENGE WERE NOT APPLICABLE. THE OUTCOME OF THE DEVICE OCCLUSION EVENT WAS UNKNOWN. THIS CASE WAS CONSIDERED SERIOUS. THE REPORTABILITY OF THIS CASE WAS EXPEDITED. THIS CASE HAS DEVICE COMPLAINT ASSOCIATED. THE INVESTIGATION REPORT WAS ASSESSED TO HAVE THE POSSIBILITY OF CAUSING ANY FUTURE HARM TO OTHER USERS OF THE PRODUCT.

Additional Manufacturer Narrative

THIS IS DEFAULT TEXT CONFIGURED FOR BLOCK H10.

Description of Event or Problem

NO AIR COULD BE PASSED THROUGH THE ATTACHED TUBING, SUGGESTING THE BLOCKAGE HAD TO DEAL WITH THE TUBING [DEVICE OCCLUSION] NO ADVERSE EVENT [NO ADVERSE EVENT]. CASE NARRATIVE: THIS INITIAL SPONTANEOUS REPORT CONCERNS EVENTS OF DEVICE OCCLUSION AND NO ADVERSE EVENT IN A MALE PATIENT (AGE AND RACE WERE NOT REPORTED) FROM THE UNITED STATES. THE PATIENT'S AGE AT THE TIME OF EVENT EXPERIENCE WAS NOT REPORTED. ON 07-JAN-2026, AMNEAL PHARMACEUTICALS RECEIVED INFORMATION FROM A CERTIFIED PHYSICIAN ASSISTANT VIA AN EMAIL CONCERNING THE ABOVE-MENTIONED EVENT EXPERIENCED WHILE ON LIORESAL (BACLOFEN) INJECTION. ADDITIONAL SIGNIFICANT INFORMATION (#1) WAS RECEIVED ON 16-JAN-2026 FROM THE CERTIFIED PHYSICIAN ASSISTANT VIA A TELEPHONE CALL. NEW INFORMATION INCLUDED PRODUCT DETAILS (STRENGTH, NDC, RECEIVED DATE) AND NARRATIVE WAS UPDATED. THE PATIENT WAS BEING TREATED WITH LIORESAL INJECTION, 10 MG/5 ML VIA INTRATHECAL ROUTE (DOSE, FREQUENCY, AND THERAPY DATES WERE NOT REPORTED) (NDC: 70121-2505-2, LOT NO: 8325301 AND EXP DATE: 30-APR-2027) FOR AN UNKNOWN INDICATION. THE PATIENT IS A WHEELCHAIR USER. HISTORY OF PROCEDURE INCLUDED MEDICAL DEVICE IMPLANTATION. CONCURRENT CONDITIONS, CO-SUSPECT MEDICATION, MEDICAL HISTORY, HISTORY OF PROCEDURES, CONCOMITANT MEDICATION, ALLERGIES, SMOKING, ALCOHOL CONSUMPTION, RECREATIONAL DRUG USE, AND LABORATORY TEST USE WERE NOT REPORTED. ON 23-DEC-2025, THE HEALTH CARE PROVIDER RECEIVED THE SEALED MEDICATION KIT AND STATED THAT ON AN UNKNOWN DATE WHILE USING IT, HE OBSERVED THAT THE TUBE WAS NOT ALLOWING ANYTHING TO PASS THROUGH IT AND THEY WERE UNABLE TO PULL THE NEEDLE. THE PATIENT WAS POSITIONED RECLINED BACK IN HIS WHEELCHAIR, WITH THE ARM OF THE WHEELCHAIR RAISED FOR BETTER ACCESS TO THE PUMP AND TO CREATE AN ADEQUATE STERILE FIELD. THE PUMP SITE WAS THOROUGHLY CLEANED WITH ALCOHOL AND BETADINE. THE SITE WAS ALLOWED TO DRY FOR 3 MINUTES. USING STERILE GLOVES, A STERILE DRAPE WAS PLACED, EXPOSING THE PUMP SITE. A 22-GAUGE NEEDLE WAS ASSEMBLED TO THE EXTENSION SET AND EMPTY SYRINGE THAT CAME WITH THE REFILL KIT. THE CLAMP WAS CLOSED ON THE EXTENSION SET. THE STERILE REFILL TEMPLATE WAS ALIGNED WITH THE PUMP EDGES. A 22-GAUGE NEEDLE WAS INSERTED PERPENDICULAR TO THE PUMP SURFACE, THROUGH THE CENTER OF THE TEMPLATE, IN THE CENTER OF THE RESERVOIR PORT. THE NEEDLE EASILY PASSED THROUGH THE SILICONE SEPTUM AND HIT THE METAL BOTTOM OF THE RESERVOIR PORT. THE CLAMP WAS OPENED; HOWEVER, NO FLUID WAS EXTRACTED ON THE INITIAL ATTEMPT, AND THE SYRINGE PLUNGER WAS UNABLE TO BE DRAWN BACK DUE TO PRESSURE. THE NEEDLE WAS REPOSITIONED INSIDE THE RESERVOIR PORT IN CASE IT HAD BEEN BLOCKED, AND ONCE AGAIN AN ATTEMPT WAS MADE TO DRAW OUT THE FLUID, AND ONCE AGAIN NO FLUID AND THE SYRINGE PLUNGER COULD NOT BE DRAWN BACK DUE TO PRESSURE. THE SYRINGE WAS DETACHED AND CHECKED FOR BLOCKAGE, BUT ONCE DISCONNECTED FROM THE TUBE IT WAS ABLE TO MOVE FREELY. THE NEEDLE WAS REMOVED AND CHECKED FOR BLOCKAGE, AND FLUID COULD BE SEEN IN THE NEEDLE TIP BUT WAS EASILY CLEARED, AND ONCE AGAIN NO BLOCKAGE WAS FOUND. THE TUBING WAS REATTACHED TO THE SYRINGE WITHOUT THE NEEDLE AND TESTED BY TRYING TO PUSH AIR THROUGH. NO AIR COULD BE PASSED THROUGH THE ATTACHED TUBING, SUGGESTING THE BLOCKAGE HAD TO DO WITH THE TUBING. THE TUBING WAS INSPECTED AND FOUND TO BE FREE OF KINKS OR OTHER OBVIOUS SIGNS OF BLOCKAGE. AFTER THE PROCEDURE, AN ATTEMPT WAS MADE TO PASS WATER THROUGH BOTH OPENINGS OF THE TUBE WITH NO WATER BEING ABLE TO PASS THROUGH THE SYRINGE CONNECTION SIDE OF THE TUBING. THE NURSE WAS ABLE TO PROVIDE NEW STERILE TUBING FROM ANOTHER KIT AND ANOTHER ATTEMPT WAS MADE. A 22-GAUGE NEEDLE WAS ASSEMBLED TO THE EXTENSION SET AND EMPTY SYRINGE THAT CAME WITH THE REFILL KIT. THE CLAMP WAS CLOSED ON THE EXTENSION SET. THE STERILE REFILL TEMPLATE WAS ALIGNED WITH THE PUMP EDGES. A 22-GAUGE NEEDLE WAS INSERTED PERPENDICULAR TO THE PUMP SURFACE, THROUGH THE CENTER OF THE TEMPLATE, IN THE CENTER OF THE RESERVOIR PORT. THE NEEDLE EASILY PASSED THROUGH THE SILICONE SEPTUM AND HIT THE METAL BOTTOM OF THE RESERVOIR PORT. THE FLUID WITHDRAWN WAS CLEAR, WITHOUT EVIDENCE OF BLOOD. THE REMAINDER OF THE PROCEDURE WAS ABLE TO BE COMPLETED WITHOUT FURTHER COMPLICATIONS. LAST ACTION TAKEN WITH LIORESAL (BACLOFEN) IN RELATION TO DEVICE OCCLUSION WAS NOT APPLICABLE. DE-CHALLENGE AND RE-CHALLENGE WERE NOT APPLICABLE. THE OUTCOME OF THE DEVICE OCCLUSION EVENT WAS UNKNOWN. THE REPORTER ASSESSED THE CAUSALITY OF THE EVENT DEVICE OCCLUSION AS RELATED TO LIORESAL (BACLOFEN). THIS CASE WAS CONSIDERED NON-SERIOUS. THE REPORTABILITY OF THIS CASE WAS PERIODIC. ON 26-FEB-2026, THE CASE WAS RE-EVALUATED AND RECLASSIFIED AS A SERIOUS, EXPEDITED 30-DAY MALFUNCTION REPORT. THIS REASSESSMENT WAS PROMPTED BY THE RECEIPT OF TWO ADDITIONAL RELATED COMPLAINTS ¿ (B)(4) ON 17-FEB-2026 AND (B)(4) ON 25-FEB-2026. IN LIGHT OF THIS TREND OF MULTIPLE MALFUNCTION COMPLAINTS, THE CASE WAS UPGRADED TO A 30-DAY REPORT. LAST ACTION TAKEN WITH LIORESAL (BACLOFEN) IN RELATION TO DEVICE OCCLUSION WAS NOT APPLICABLE. DE-CHALLENGE AND RE-CHALLENGE WERE NOT APPLICABLE. THE OUTCOME OF THE DEVICE OCCLUSION EVENT WAS UNKNOWN. THIS CASE WAS CONSIDERED SERIOUS. THE REPORTABILITY OF THIS CASE WAS EXPEDITED.