FOLFUSOR

Additional Manufacturer Narrative

B3/D10: THE EVENTS OCCURRED BETWEEN MACH - APRIL, 2026. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED THAT EIGHTEEN (18) SMALL VOLUME FOLFUSORS HAD WHITE POWDER EITHER ON THE END OF THE IN THE CREVICES OF THE BLUE CAP/CONNECTOR AND WAS PREDOMINANTLY PRESENT IN THE FILL PORT AT THE POINT OF FINAL RELEASE. THE ISSUE WAS NOTICED PRIOR TO PATIENT USE. THE DEVICES WERE FILLED WITH 5-FLUOROURACIL (5-FU) AND SALINE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.