NI

Description of Event or Problem

IT WAS REPORTED THAT AN UNSPECIFIED ELASTOMERIC PUMP LEAKED FROM AN UNSPECIFIED LOCATION. THE DEVICE WAS FILLED WITH 5-FLUOROURACIL. THIS OCCURRED DURING PREPARATION. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

Additional Manufacturer Narrative

D4: UNIQUE IDENTIFIER (UDI) #: THE PRODUCT CODE (01) AND LOT NUMBER (10) ARE UNKNOWN; THEREFORE, THE UDI IS NOT AVAILABLE. E1: INITIAL REPORTER PHONE NO.: (B)(6). THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.