FOLFUSOR

Additional Manufacturer Narrative

E1: INITIAL REPORTER ADDRESS: (B)(6). 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 AN UNSPECIFIED LOCATION. FLUID ACCUMULATION WAS OBSERVED WITHIN THE SEALED BAG AND WAS INITIALLY IDENTIFIED PRIOR TO PATIENT USE. THE DEVICE WAS FILLED WITH 64.38 ML 5-FLUOROURACIL (5-FU), 6.39 ML ONCOFOLIC, AND 0.9% SODIUM CHLORIDE SOLUTION HAVING FINAL VOLUME OF 96 ML. THE DEVICE WAS REPACKAGED INTO A NEW SEALED BAG, AND ADDITIONAL FLUID LEAKAGE WAS OBSERVED AFTER SEVERAL DAYS. THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION WAS AVAILABLE.