BACLOFEN

Additional Manufacturer Narrative

THIS IS DEFAULT TEXT CONFIGURED FOR BLOCK H10.

Description of Event or Problem

WASN'T ABLE TO INJECT OR PULL AIR THROUGH THE TUBING EVEN WITHOUT THE NEEDLE ATTACHED [DEVICE DEFECTIVE]. NO ADVERSE EVENT [NO ADVERSE EVENT]. CASE NARRATIVE: THIS INITIAL SPONTANEOUS REPORT CONCERNS DEVICE DEFECTIVE AND NO ADVERSE EVENT IN A PATIENT (AGE, GENDER, AND RACE WERE NOT REPORTED) FROM THE UNITED STATES. THE PATIENT'S AGE AT THE TIME OF EVENT EXPERIENCE WAS NOT REPORTED. ON 16-MAR-2026, AMNEAL PHARMACEUTICALS RECEIVED INFORMATION FROM A OTHER REPORTER VIA AN EMAIL CONCERNING THE ABOVE-MENTIONED ADVERSE EVENTS EXPERIENCED BY THE PATIENT WHILE ON LIORESAL (BACLOFEN) INJECTION. THE PATIENT WAS BEING TREATED WITH LIORESAL (BACLOFEN) INJECTION 40 MG/20 ML (2000 MCG/ML) (NDC: 70121-2505-2, LOT NO: 8325301, EXP.DATE: 30-APR-2027) (DOSE, FREQUENCY, ROUTE, STRENGTH, AND THERAPY DATES WERE NOT REPORTED) FOR AN UNKNOWN INDICATION. HISTORY OF PROCEDURE INCLUDED MEDICAL DEVICE IMPLANTATION AND MEDICAL DEVICE REPLACEMENT ON 29-JAN-2026. CO-SUSPECT MEDICATION, CONCOMITANT MEDICATION, MEDICAL HISTORY, HISTORY OF ALLERGIES, SMOKING, ALCOHOL CONSUMPTION, AND RECREATIONAL DRUG USE WERE NOT REPORTED. LABORATORY TESTS WERE NOT REPORTED. IT WAS REPORTED THAT, THE FELLOW WAS PERFORMING A ROUTINE PUMP REFILL IN CLINIC UNDER SUPERVISION. SHE FELT THE NEEDLE ENTER THE PATIENT'S RESERVOIR REFILL PORT BUT WAS NOT ABLE TO DRAW BACK ANY FLUID AFTER UNCLAMPING THE TUBING (12.2 CC FLUID WAS EXPECTED TO BE IN THE RESERVOIR). SHE REPOSITIONED THE NEEDLE MULTIPLE TIMES SINCE WE THOUGHT MAYBE SHE WAS HITTING SCAR TISSUE INSTEAD OF ACTUALLY DIRECTING THE NEEDLE INTO THE RESERVOIR PORT. ULTIMATELY, SHE REMOVED THE NEEDLE FROM THE PATIENT'S SKIN IN PREPARATION TO RESTART THE PROCEDURE USING ULTRASOUND GUIDANCE. AT THAT POINT THEY DIRECTED HER TO CHANGE THE NEEDLE IN CASE IT CONTAINED A BLOOD CLOT OR WAS OTHERWISE OBSTRUCTED, AT WHICH POINT SHE FOUND THAT SHE WASN'T ABLE TO INJECT OR PULL AIR THROUGH THE TUBING EVEN WITHOUT THE NEEDLE ATTACHED. THE PATIENT WAS MADE AWARE OF THE ISSUE. THEY OPENED A SPARE KIT AND RESTARTED THE PROCEDURE, EASILY REMOVED 12CC OF FLUID FROM THE RESERVOIR AND REFILLED THE PUMP WITHOUT FURTHER COMPLICATION. LAST ACTION TAKEN WITH LIORESAL IN RELATION TO DEVICE DEFECTIVE AND NO ADVERSE EVENT WAS NOT APPLICABLE. DE-CHALLENGE AND RE-CHALLENGE WERE NOT APPLICABLE. THE OUTCOME OF THE DEVICE DEFECTIVE AND NO ADVERSE EVENT EVENTS WAS UNKNOWN. THE REPORTER ASSESSED THE CAUSALITY OF DEVICE DEFECTIVE AS RELATED TO THE LIORESAL REFILL KIT. THE REPORTER DID NOT PROVIDE CAUSALITY OF THE EVENT NO ADVERSE EVENT WITH LIORESAL. THIS CASE WAS CONSIDERED SERIOUS. THE REPORTABILITY OF THIS CASE WAS EXPEDITED. THIS SIGNIFICANT FOLLOW UP (#1) 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

WASN'T ABLE TO INJECT OR PULL AIR THROUGH THE TUBING EVEN WITHOUT THE NEEDLE ATTACHED: [DEVICE DEFECTIVE]. NO ADVERSE EVENT. CASE NARRATIVE: THIS INITIAL SPONTANEOUS REPORT CONCERNS DEVICE DEFECTIVE AND NO ADVERSE EVENT IN A PATIENT (AGE, GENDER, AND RACE WERE NOT REPORTED) FROM THE UNITED STATES. THE PATIENT'S AGE AT THE TIME OF EVENT EXPERIENCE WAS NOT REPORTED. ON 16-MAR-2026, AMNEAL PHARMACEUTICALS RECEIVED INFORMATION FROM ANOTHER REPORTER VIA AN EMAIL CONCERNING THE ABOVE-MENTIONED ADVERSE EVENTS EXPERIENCED BY THE PATIENT WHILE ON LIORESAL (BACLOFEN) INJECTION. THE PATIENT WAS BEING TREATED WITH LIORESAL (BACLOFEN) INJECTION 40 MG/20 ML (2000 MCG/ML) (NDC: 70121-2505-2, LOT NO: 8325301, EXP. DATE: 30-APR-2027) (DOSE, FREQUENCY, ROUTE, STRENGTH, AND THERAPY DATES WERE NOT REPORTED) FOR AN UNKNOWN INDICATION. HISTORY OF PROCEDURE INCLUDED MEDICAL DEVICE IMPLANTATION AND MEDICAL DEVICE REPLACEMENT ON (B)(6) 2026. CO-SUSPECT MEDICATION, CONCOMITANT MEDICATION, MEDICAL HISTORY, HISTORY OF ALLERGIES, SMOKING, ALCOHOL CONSUMPTION, AND RECREATIONAL DRUG USE WERE NOT REPORTED. LABORATORY TESTS WERE NOT REPORTED. IT WAS REPORTED THAT, THE FELLOW WAS PERFORMING A ROUTINE PUMP REFILL IN CLINIC UNDER SUPERVISION. SHE FELT THE NEEDLE ENTER THE PATIENT'S RESERVOIR REFILL PORT BUT WAS NOT ABLE TO DRAW BACK ANY FLUID AFTER UNCLAMPING THE TUBING (12.2 CC FLUID WAS EXPECTED TO BE IN THE RESERVOIR). SHE REPOSITIONED THE NEEDLE MULTIPLE TIMES SINCE WE THOUGHT MAYBE SHE WAS HITTING SCAR TISSUE INSTEAD OF ACTUALLY DIRECTING THE NEEDLE INTO THE RESERVOIR PORT. ULTIMATELY, SHE REMOVED THE NEEDLE FROM THE PATIENT'S SKIN IN PREPARATION TO RESTART THE PROCEDURE USING ULTRASOUND GUIDANCE. AT THAT POINT THEY DIRECTED HER TO CHANGE THE NEEDLE IN CASE IT CONTAINED A BLOOD CLOT OR WAS OTHERWISE OBSTRUCTED, AT WHICH POINT SHE FOUND THAT SHE WASN'T ABLE TO INJECT OR PULL AIR THROUGH THE TUBING EVEN WITHOUT THE NEEDLE ATTACHED. THE PATIENT WAS MADE AWARE OF THE ISSUE. THEY OPENED A SPARE KIT AND RESTARTED THE PROCEDURE, EASILY REMOVED 12CC OF FLUID FROM THE RESERVOIR AND REFILLED THE PUMP WITHOUT FURTHER COMPLICATION. LAST ACTION TAKEN WITH LIORESAL IN RELATION TO DEVICE DEFECTIVE AND NO ADVERSE EVENT WAS NOT APPLICABLE. DE-CHALLENGE AND RE-CHALLENGE WERE NOT APPLICABLE. THE OUTCOME OF THE DEVICE DEFECTIVE AND NO ADVERSE EVENT EVENTS WAS UNKNOWN. THE REPORTER ASSESSED THE CAUSALITY OF DEVICE DEFECTIVE AS RELATED TO THE LIORESAL REFILL KIT. THE REPORTER DID NOT PROVIDE CAUSALITY OF THE EVENT NO ADVERSE EVENT WITH LIORESAL. THIS CASE WAS CONSIDERED SERIOUS. THE REPORTABILITY OF THIS CASE WAS EXPEDITED.