FIRAZYR

Additional Manufacturer Narrative

INVESTIGATION IS PENDING.

Description of Event or Problem

WHEN THE PHYSICIAN ATTEMPTED TO ADMINISTER FIRAZYR, THEY FOUND THAT THE PISTON (PLUNGER ROD) AND THE RUBBER PART HAD COME APART, POSSIBLY DUE TO A SYRINGE DEFECT. THEY ALSO SAID THAT, ALTHOUGH IT MAY HAVE BEEN JUST THEIR IMPRESSION, THERE SEEMED TO BE A LOT OF AIR INSIDE THE SYRINGE. ADMINISTRATION TO THE PATIENT HAS ALREADY BEEN COMPLETED WITH THE PRODUCT IN QUESTION BECAUSE IT COULD BE DELIVERED BY PUSHING IT IN, BUT THE SYRINGE DEFECT IS CONCERNING BECAUSE THIS PRODUCT IS USED DURING SEIZURE EPISODES. THE PHYSICIAN WOULD LIKE THIS KIND OF DEFECT TO BE PREVENTED. THIS TIME, DURING THE PRE-ADMINISTRATION CHECK, IT SEEMED THAT THERE WAS A LARGE AMOUNT OF AIR IN THE TIP OF THE SYRINGE. WHEN THEY TRIED TO REMOVE THE AIR BY SLIGHTLY PUSHING THE SYRINGE, A SMALL AMOUNT OF LIQUID CAME OUT FROM THE TIP. WHEN THEY PULLED THE SYRINGE BACK, THE TIP PORTION USED FOR PUSHING THE PLUNGER AND THE RUBBER HAD COME APART. THERE WAS NO DAMAGE TO THE PACKAGING (SYRINGE TRAY) AND NO LEAKAGE BEFORE ADMINISTRATION. THIS WAS ADMINISTERED AT A CLINIC THIS TIME, BUT THERE WAS CONCERN THAT IF THIS HAD HAPPENED AT THE PATIENT'S HOME, IT MIGHT NOT HAVE BEEN ADMINISTERED PROPERLY. PHYSICIANS WERE ALSO QUESTIONS ABOUT THE FREQUENCY OF THIS KIND OF EVENT. ADDITIONAL INFORMATION RECEIVED (B)(6) 2026: LOT NUMBER AND SAMPLE PHOTOGRAPHS RECEVIED. (B)(6) 2026 JAPAN LOC NOTE: · DID THE PATIENT MISS THE DOSE: NO, BASED ON THE COMPLAINT DESCRIPTION. · WAS THE SEAL/BOX/CARTON/TRAY DAMAGED, BROKEN, OR MISSING PRIOR TO USE: NO, BASED ON THE COMPLAINT DESCRIPTION. · WHEN YOU INSPECTED THE SYRINGE, WAS THERE ANY DAMAGE OR LOOSE COMPONENTS: NO, BUT THE PHYSICIAN FELT THAT THERE APPEARED TO BE A LARGE AMOUNT OF AIR IN THE SYRINGE. · HOW WAS THE NEEDLE CAP SEAL REMOVED? [?] TWIST OFF, [?] PEEL OFF: INFORMATION NOT AVAILABLE · WHICH NEEDLE WAS USED? WAS THIS THE FIRST TIME YOU'VE USED THIS NEEDLE: INFORMATION NOT AVAILABLE · HOW WAS THE NEEDLE ATTACHED TO THE SYRINGE? [?] PUSH [?] TWIST: INFORMATION NOT AVAILABLE · DID THE NEEDLE SEEM SECURELY ATTACHED TO THE SYRINGE: INFORMATION NOT AVAILABLE · AFTER CLEANING THE INJECTION SITE, HOW WAS THE SKIN HANDLED DURING INJECTION: INFORMATION NOT AVAILABLE · WAS THERE ANYTHING OBSERVED AT THE INJECTION SITE PRIOR TO INSERTION OF NEEDLE? [?] ECZEMA [?] RASH [?] BRUISING [?] SCAR: INFORMATION NOT AVAILABLE · HOW DID YOU INSERT THE NEEDLE IN THE SKIN, WHICH ANGLE (I.E THE ANGLE BETWEEN THE SYRINGE AND THE SKIN): INFORMATION NOT AVAILABLE SINCE THE ISSUE WAS DISCOVERED BEFORE ADMINISTRATION · DID THE NEEDLE PIERCE THE SKIN: YES, IN FINALLY. · IF LEAKAGE WAS OBSERVED, WHEN DID THE LEAKAGE HAPPEN? CHOOSE ONE BELOW: BEFORE THE NEEDLE WAS INSERTED IN THE SKIN WHEN REMOVING THE AIR. · IF LEAKAGE WAS OBSERVED, WHERE WAS THE LEAKING MEDICATION: INFORMATION NOT AVAILABLE · IF LEAKAGE WAS OBSERVED, IS IT POSSIBLE TO QUANTIFY (DROPLET, HALF DOSE, FULL DOSE OR SOMETHING IN BETWEEN?): DROPLET. · DID YOU RECEIVE TRAINING ON HOW TO USE THE SYRINGE? IF SO, HOW WERE YOU TRAINED (BY WHOM): INFORMATION NOT AVAILABLE.