NI

Description of Event or Problem

IT WAS REPORTED THAT AN UNSPECIFIED ELASTOMERIC PUMP UNDERINFUSED DURING PATIENT INFUSION. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. 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 ADDRESS:(B)(6). E1: INITIAL REPORTER POSTAL CODE: H11: 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.