BLOOD RECIPIENT SET

Additional Manufacturer Narrative

D4: UNIQUE IDENTIFIER (UDI) #: AS THE LOT NUMBER IS UNKNOWN, THE UDI WILL CONSIST OF THE PRIMARY DI ONLY. E1: INITIAL REPORTER PHONE NO.: (B)(6). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED THAT AN ADD-ON LARGE STANDARD BLOOD FILTER LEAKED RED BLOOD CELLS (RBCS) OUTSIDE OF THE BLOOD FILTER HOUSING (AT THE FILTER JUNCTION) DURING A TRANSFUSION. AFTER A SMALL AMOUNT OF LEAK WAS DISCOVERED, THE NURSE WIPED AWAY THE BLOOD AND APPLIED ADHESIVE TAPE TO THE AREA TO LIMIT THE LEAKAGE AND ALLOW THE TRANSFUSION TO CONTINUE. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.