BACLOFEN

Description of Event or Problem

KIT HAD DEFECTIVE TUBING [DEVICE ISSUE]. TUBING CONNECTED TO THE NEEDLE WAS SEALED OFF [DEVICE OCCLUSION]. NO ADVERSE EVENT [NO ADVERSE EVENT]. CASE NARRATIVE: THIS INITIAL SPONTANEOUS REPORT CONCERNS OF EVENTS DEVICE ISSUE, 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 08-JUN-2026, AMNEAL PHARMACEUTICALS RECEIVED INFORMATION FROM A PHARMACIST VIA AN EMAIL CONCERNING THE ABOVE-MENTIONED ADVERSE EVENTS EXPERIENCED BY THE PATIENT WHILE ON LIORESAL (BACLOFEN) INJECTION. ADDITIONAL SIGNIFICANT INFORMATION (#1) WAS RECEIVED ON 09-JUN-2026 FROM THE PHARMACIST VIA AN EMAIL. NEW INFORMATION INCLUDED; PRODUCT DETAILS (NDC, LOT NO, S/N) AND CASE NARRATIVE WERE UPDATED. ADDITIONAL SIGNIFICANT INFORMATION (#2) WAS RECEIVED ON 12-JUN-2026 FROM THE PHARMACIST VIA AN EMAIL. NEW INFORMATION WAS UPDATED IN NARRATIVE. THE PATIENT WAS BEING TREATED WITH LIORESAL (BACLOFEN) INJECTION 2000 MCG/ML (NDC: 70121-2505-2, EXP. DATE: 30-APR-2027, LOT NO: 8325301, KIT NO: 8566, S/N: 3000028775, PACKAGE SIZE: 40 ML) (DOSE, FREQUENCY, ROUTE, STRENGTH, AND THERAPY DATES WERE NOT REPORTED), INTRATHECALLY 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. ON (B)(6) 2026, THEY HAD A KIT WITH DEFECTIVE TUBING, AND THE NURSE WAS UNABLE TO ASPIRATE ANY MEDICATION FROM THE PUMP. IT APPEARED THAT THE HUB AT THE TUBING CONNECTED TO THE NEEDLE WAS SEALED OFF. THE NURSE HAD A SPARE TUBING SET AVAILABLE AND WAS ABLE TO UTILIZE IT WITH NO ISSUES. SWITCHED FOR MEDTRONIC KIT AND MEDICATION ASPIRATED WITH EASE. THE KIT WAS SEALED, NO EVIDENCE OF OPENING OR TAMPERING AT TIME OF RECEIPT. IT WAS FURTHER REPORTED THAT, THERE WERE NO SAMPLES AVAILABLE, AS NURSES WERE IN THE PATIENT¿S HOMES AND HAD TO ADMINISTER THE MEDICATIONS. IT WAS FURTHER CLARIFIED THAT, MEDICATION WAS NOT MIXED WITH ANOTHER PRODUCT, STORED AT CONTROLLED ROOM TEMPERATURE. THE EVENT OCCURED BEFORE ADMINISTRATION OF THE DRUG. THE WERE ABLE TO ADMINISTER FULL DOSE TO THE PATIENT USING ANOTHER TUBING. LAST ACTION TAKEN WITH LIORESAL IN RELATION TO DEVICE ISSUE, DEVICE OCCLUSION AND NO ADVERSE EVENT WAS NOT APPLICABLE. DE-CHALLENGE AND RE-CHALLENGE WERE NOT APPLICABLE. THE OUTCOME OF EVENTS DEVICE ISSUE, DEVICE OCCLUSION AND NO ADVERSE EVENT WERE UNKNOWN. THE REPORTER DID NOT ASSESS THE CAUSALITY OF DEVICE ISSUE, DEVICE OCCLUSION AND NO ADVERSE EVENT WITH LIORESAL. THIS CASE WAS CONSIDERED SERIOUS. THE REPORTABILITY OF THIS CASE WAS EXPEDITED.