BACLOFEN

Additional Manufacturer Narrative

THIS IS DEFAULT TEXT CONFIGURED FOR BLOCK H10.

Description of Event or Problem

SAME ISSUE WITH ANOTHER KIT - AND THIS TIME WE KEPT THE TUBING/WASN'T ABLE TO INJECT OR PULL AIR THROUGH THE TUBING EVEN WITHOUT THE NEEDLE ATTACHED [DEVICE OCCLUSION] NO ADVERSE EVENT [NO ADVERSE EVENT]. CASE NARRATIVE: THIS INITIAL SPONTANEOUS REPORT CONCERNS DEVICE OCCLUSION 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 (B)(6) 2026, AMNEAL PHARMACEUTICALS RECEIVED INFORMATION FROM OTHER REPORTER VIA AN EMAIL CONCERNING THE ABOVE-MENTIONED ADVERSE EVENTS EXPERIENCED BY THE PATIENT WHILE ON LIORESAL (BACLOFEN) INJECTION. ADDITIONAL SIGNIFICANT FOLLOW UP (#1) INFORMATION WAS RECEIVED ON (B)(6) 2026. NEW INFORMATION RECEIVED INCLUDES INVESTIGATION REPORT, ATTACHED WITH THIS CASE. THE PATIENT WAS BEING TREATED WITH LIORESAL (BACLOFEN) INJECTION (LOT NO: 8325301, EXP. DATE: 30-APR-2027, NDC AND SERIAL NUMBER WERE NOT REPORTED) (DOSE, FREQUENCY, ROUTE, STRENGTH, AND THERAPY DATES WERE NOT REPORTED) FOR AN UNKNOWN INDICATION. CO-SUSPECT MEDICATION, CONCOMITANT MEDICATION, MEDICAL HISTORY, HISTORY OF PROCEDURE, ALLERGIES, SMOKING, ALCOHOL CONSUMPTION, AND RECREATIONAL DRUG USE WERE NOT REPORTED. LABORATORY TESTS WERE NOT REPORTED. IT WAS REPORTED THAT, THEY HAD SAME ISSUE THAT THEY WEREN'T ABLE TO INJECT OR PULL AIR THROUGH THE TUBING EVEN WITHOUT THE NEEDLE ATTACHED WITH ANOTHER KIT AND THIS TIME THEY KEPT THE TUBING. AAS 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. LAST ACTION TAKEN WITH LIORESAL IN RELATION TO DEVICE OCCLUSION AND NO ADVERSE EVENT WAS NOT APPLICABLE. DE-CHALLENGE AND RE-CHALLENGE WERE NOT APPLICABLE. THE OUTCOME OF THE DEVICE OCCLUSION AND NO ADVERSE EVENT EVENTS WAS UNKNOWN. THE REPORTER ASSESSED THE CAUSALITY OF DEVICE OCCLUSION 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 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.