FOLFUSOR

Additional Manufacturer Narrative

E1: INITIAL REPORTER FIRST NAME: (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 BETWEEN THE COLORED CAP AND THE PLASTIC HOUSING CONTAINING THE BALLOON. THE LEAK WAS IDENTIFIED DURING REMOVAL OF THE DEVICE FROM THE TRANSPORT CONTAINER AND PREPARATION FOR ADMINISTRATION. THE DEVICE WAS FILLED WITH 104 ML OF 5 FLUOROURACIL AND 17 ML OF 0.9% SALINE FOR A TOTAL FILL VOLUME OF 121 ML. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.