BACLOFEN

Additional Manufacturer Narrative

THIS IS DEFAULT TEXT CONFIGURED FOR BLOCK H10.

Description of Event or Problem

CAN'T WITHDRAW FLUID INITIAL. 2/3 FLUID STARTED FLOWING WITH EXTREME BACK PRESSURE ON SYRINGE AFTER APPROXIMATELY 1 MINUTE/CHANGED NEEDLES TO THAT FROM AN OLDER REFILL KIT BECAUSE STILL COULD NOT GET FLOW [DEVICE OCCLUSION] NO ADVERSE EVENT [NO ADVERSE EVENT]. CASE NARRATIVE: THIS INITIAL SPONTANEOUS REPORT CONCERNS DEVICE OCCLUSION AND NO ADVERSE EVENT IN A PATIENT (GENDER, AGE, AND RACE WERE NOT REPORTED) FROM THE UNITED STATES. THE PATIENT'S AGE AT THE TIME OF EVENT EXPERIENCE WAS NOT REPORTED. ON 17-FEB-2026, AMNEAL PHARMACEUTICALS RECEIVED INFORMATION FROM A HEALTH CARE PROFESSIONAL VIA AN EMAIL CONCERNING ABOVE-MENTIONED EVENT EXPERIENCED WHILE ON AMNEAL'S LIORESAL (BACLOFEN) INJECTION. THE PATIENT WAS BEING TREATED WITH LIORESAL (BACLOFEN) INJECTION 2000 MICROGRAM/ML (LOT 8368301, EXP 03-NOV-2027) INTRATHECALLY (THERAPY DATE NOT REPORTED) FOR AN UNKNOWN INDICATION. HISTORY OF PROCEDURE INCLUDED MEDICAL DEVICE IMPLANTATION. CONCURRENT CONDITIONS, CONCOMITANT MEDICATION, MEDICAL HISTORY, HISTORY OF PROCEDURES, HISTORY OF ALLERGIES, HISTORY OF SMOKING, ALCOHOL CONSUMPTION, RECREATIONAL DRUG USE, HISTORICAL DRUG USE, AND LABORATORY TESTS WERE NOT REPORTED. ON 17-FEB-2026, FOR THREE PATIENTS IN A ROW THE REPORTER HAD ACCESSED THEIR PUMPS BUT COULDN'T WITHDRAW FLUID INITIALLY. TWO OUT OF THREE PATIENTS¿ FLUID STARTED FLOWING WITH EXTREME BACK PRESSURE ON THE SYRINGE AFTER APPROXIMATELY ONE MINUTE, AND FOR ONE PATIENT, SHE CHANGED NEEDLES TO ONE FROM AN OLDER REFILL KIT BECAUSE SHE STILL COULD NOT GET FLOW. THESE WERE EASY-TO-ACCESS PUMPS WITH NO CONCERN FOR NEEDLE DAMAGE DURING ACCESS. LAST ACTION TAKEN WITH LIORESAL 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 PROVIDED THE CAUSALITY OF THE EVENT DEVICE OCCLUSION AS RELATED TO LIORESAL. THIS CASE WAS CONSIDERED SERIOUS. THE REPORTABILITY OF THIS CASE WAS EXPEDITED.

Additional Manufacturer Narrative

THIS IS DEFAULT TEXT CONFIGURED FOR BLOCK H10.

Description of Event or Problem

CAN'T WITHDRAW FLUID INITIAL. 2/3 FLUID STARTED FLOWING WITH EXTREME BACK PRESSURE ON SYRINGE AFTER APPROXIMATELY 1 MINUTE/CHANGED NEEDLES TO THAT FROM AN OLDER REFILL KIT BECAUSE STILL COULD NOT GET FLOW [DEVICE OCCLUSION]. NO ADVERSE EVENT. CASE NARRATIVE: THIS INITIAL SPONTANEOUS REPORT CONCERNS DEVICE OCCLUSION AND NO ADVERSE EVENT IN A PATIENT (GENDER, AGE, 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 A HEALTH CARE PROFESSIONAL VIA AN EMAIL CONCERNING ABOVE-MENTIONED EVENT EXPERIENCED WHILE ON AMNEAL'S LIORESAL (BACLOFEN) INJECTION. THE PATIENT WAS BEING TREATED WITH LIORESAL (BACLOFEN) INJECTION 2000 MICROGRAM/ML (LOT 8368301, EXP 03-NOV-2027) INTRATHECALLY (THERAPY DATE NOT REPORTED) FOR AN UNKNOWN INDICATION. HISTORY OF PROCEDURE INCLUDED MEDICAL DEVICE IMPLANTATION. CONCURRENT CONDITIONS, CONCOMITANT MEDICATION, MEDICAL HISTORY, HISTORY OF PROCEDURES, HISTORY OF ALLERGIES, HISTORY OF SMOKING, ALCOHOL CONSUMPTION, RECREATIONAL DRUG USE, HISTORICAL DRUG USE, AND LABORATORY TESTS WERE NOT REPORTED. ON (B)(6) 2026, FOR THREE PATIENTS IN A ROW THE REPORTER HAD ACCESSED THEIR PUMPS BUT COULDN'T WITHDRAW FLUID INITIALLY. TWO OUT OF THREE PATIENTS¿ FLUID STARTED FLOWING WITH EXTREME BACK PRESSURE ON THE SYRINGE AFTER APPROXIMATELY ONE MINUTE, AND FOR ONE PATIENT, SHE CHANGED NEEDLES TO ONE FROM AN OLDER REFILL KIT BECAUSE SHE STILL COULD NOT GET FLOW. THESE WERE EASY-TO-ACCESS PUMPS WITH NO CONCERN FOR NEEDLE DAMAGE DURING ACCESS. LAST ACTION TAKEN WITH LIORESAL 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 PROVIDED THE CAUSALITY OF THE EVENT DEVICE OCCLUSION AS RELATED TO 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.