FOLFUSOR

Additional Manufacturer Narrative

H4: THE LOT WAS MANUFACTURED BETWEEN AUGUST 19, 2025 AND AUGUST 20, 2025. H11: A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THE DEVICE WAS NOT RECEIVED FOR EVALUATION; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED THAT A SMALL VOLUME FOLFUSORS HAD FLOW ISSUE DURING PATIENT INFUSION. THE ADMINISTRATION DURATION WAS 48 HOURS; HOWEVER, AT THE 48 HOUR MARK, THE ENTIRE CONTENTS OF THE DIFFUSER HAD NOT BEEN FULLY ADMINISTERED. ADMINISTRATION WAS THEREFORE EXTENDED TO 72 HOURS, FOLLOWED BY THE REMOVAL OF THE DIFFUSERS. THE DEVICES WERE FILLED WITH A TOTAL VOLUME OF 97 ML CONTAINING FLUOROURACIL AND 5% GLUCOSE. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.