INFUSOR

Additional Manufacturer Narrative

SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED THAT A SMALL VOLUME INFUSOR UNDER INFUSED DURING INFUSION. THE INFUSION WAS NOT COMPLETED AFTER 48 HOURS AND IT TOOK SEVERAL MORE HOURS TO FINISH. THE DEVICE WAS FILLED WITH FLUOROURACIL AND SALINE. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: D4, D9, H3, H4, H6(UPDATE CODES), H11. H4: THE LOT WAS MANUFACTURED BETWEEN SEPTEMBER 3-5, 2025. H11: THE DEVICE WAS RECEIVED FOR EVALUATION WITHOUT ANY REMAINING FLUID IN THE BLADDER. VISUAL INSPECTION OF THE RETURNED SAMPLE DID NOT IDENTIFY ANY ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. A FUNCTIONAL FLOW RATE TEST WAS PERFORMED, AND THE FLOW RATES WERE FOUND TO BE WITHIN THE PRODUCT FLOW RATE SPECIFICATION RANGE. THE INFUSOR SAMPLE WAS DETERMINED TO BE A CONFORMING PRODUCT. THE REPORTED CONDITION WAS NOT VERIFIED. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.