FOLFUSOR

Description of Event or Problem

IT WAS REPORTED THAT THE BALLOON OF A SMALL VOLUME FOLFUSOR 'EXPLODED' AND THE LID HAS 'FLOWN OFF'. THE ISSUE WAS NOTICED WHILE FILLING THE DEVICE WITH 5-FLUOROURACIL (5-FU), RESULTING IN A SPILL INCIDENT DURING PREPARATION OF THE BATCH. THE FINAL VOLUME OF THE DEVICE WAS 20ML. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

Additional Manufacturer Narrative

E1: INITIAL REPORTER ADDRESS: (B)(6). E1: INITIAL REPORTER POSTAL CODE: (B)(6). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.