FOLFUSOR

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 FOLFUSOR LEAKED FROM THE TUBE; HOWEVER, STILL CONTAINED INSIDE THE PLASTIC SHELL CONTAINER. THIS OCCURRED PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: H4, H6(UPDATE CODES), H11. H4: THE LOT WAS MANUFACTURED BETWEEN APRIL 29-30, 2025. H11: THE ACTUAL DEVICE WAS NOT AVAILABLE; HOWEVER, A PHOTOGRAPH OF THE SAMPLE WAS PROVIDED FOR EVALUATION. VISUAL INSPECTION OF THE PHOTOGRAPH SHOWED FLUID PRESENT INSIDE THE DEVICE COVER WHICH SUGGESTED LEAK MAY HAVE OCCURRED; HOWEVER, THE PHOTO DID NOT SHOW LEAK WAS COMING FROM THE DEVICE'S TUBE. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE OF THE ISSUE 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.