BLOOD RECIPIENT SET

Additional Manufacturer Narrative

D4: UNIQUE DEVICE IDENTIFIER (UDI) # IS BASED ON THE DI INFORMATION AS NO LOT NUMBER WAS PROVIDED BY THE REPORTER. E1: INITIAL REPORTER FACILITY NAME: (B)(6). 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 PATIENT¿S BLOOD FLOWED BACK INTO A Y-TYPE BLOOD/SOLN SET. THIS OCCURRED WHILE LINES WERE FREE FLOWING SODIUM CHLORIDE (NACL) 0.9% SOLUTION BY GRAVITY IN PREPARATION FOR INFUSIONS. THE NURSE ATTEMPTED TO FLUSH THE LINES WITH GRAVITY, BUT THE PATIENT¿S BLOOD REMAINED IN THE TUBING. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION WAS ADDED TO H6. H11: THE ACTUAL DEVICE WAS NOT AVAILABLE; HOWEVER, A PHOTOGRAPH OF THE SAMPLE WAS PROVIDED FOR EVALUATION. THE RETURNED PHOTOGRAPH WAS REVIEWED, AND IT WAS NOTED THAT NO BLOOD WAS OBSERVED BACKING UP INTO THE TUBING. THE REPORTED CONDITION WAS NOT VERIFIED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.