NA

Description of Event or Problem

IT WAS REPORTED THAT A NON-DEHP THREE LEAD EXTENSION SET LEAKED FROM THE MICROBORE FILTER. THIS WAS OBSERVED UPON INSPECTION DURING PATIENT INFUSION. THE FLUID HAD BEEN INFUSING FOR APPROXIMATELY 12 HOURS, AND THE LEAK WAS DISCOVERED DUE TO WET SHEETS. 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 LOT NUMBER (10) IS UNKNOWN; THEREFORE, THE UDI NUMBER ONLY WILL CONTAIN THE DEVICE IDENTIFIER (01). THE DEVICE WAS DISCARDED 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.