FOLFUSOR

Additional Manufacturer Narrative

H4: DEVICE MANUFACTURE DATE - THE LOT WAS MANUFACTURED BETWEEN OCTOBER 8-9, 2025. THE ACTUAL DEVICE WAS NOT AVAILABLE; HOWEVER, A PHOTOGRAPH OF THE SAMPLE WAS PROVIDED FOR EVALUATION. THE RETURNED PHOTOGRAPH WAS REVIEWED, AND IT WAS NOTED THAT THERE WAS WHITE DRUG RESIDUE ON THE OUTER SURFACE OF THE DEVICE AFTER THE DEVICE WAS FILLED WITH DRUG SOLUTIONS AND STORED INSIDE A YELLOW BAG WHICH SUGGESTS THE DEVICE MAY HAVE LEAKED DURING STORAGE INSIDE THE YELLOW BAG. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE OF THE REPORTED CONDITION COULD NOT BE DETERMINED. 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.

Description of Event or Problem

IT WAS REPORTED THAT A LARGE VOLUME FOLFUSOR WAS LEAKING FROM AN UNSPECIFIED LOCATION. THE LEAK WAS OBSERVED PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.