FOLFUSOR

Additional Manufacturer Narrative

E1: INITIAL REPORTER POSTAL CODE: (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 DISCONNECTED FROM A PORT A CATH, RESULTING IN A LEAK DURING PATIENT INFUSION. THIS OCCURRED WHEN THE PATIENT WAS APPROXIMATELY 10 TO 12 HOURS INTO THE INFUSION. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.