NI

Additional Manufacturer Narrative

D4: UNIQUE IDENTIFIER (UDI) #: THE PRODUCT CODE AND LOT NUMBER ARE UNKNOWN; THEREFORE, THE UDI NUMBER COULD NOT BE COMPILED. 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.

Description of Event or Problem

IT WAS REPORTED THAT AN UNSPECIFIED ACCESS BLOOD SET LEAKED DURING A BLOOD TRANSFUSION. THE SPIKE WAS BELIEVED TO HAVE BEEN PUSHED INTO THE BAG ACCIDENTALLY. THE LEAK WAS OBSERVED DURING PATIENT INFUSION WHEN THE BAG WAS RUNNING VIA A BAXTER PUMP. THE VOLUME OF BLOOD LOSS WAS NOT REPORTED. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.