NA

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 ADDRESS: (B)(6). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED THAT A Y-TYPE BLOOD/SOLUTION SET WAS LEAKING. A BLOOD BAG WAS SPIKED AND CLAMPED APPROPRIATELY WHEN IT WAS OBSERVED THAT BLOOD BEGAN TO LEAK OUT OF THE CLAMPED AREA AND RAPIDLY FILLED THE LARGE CHAMBER RATHER THAN PROPERLY FLOWING. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: D9, E4, G2, H3, H6, H10, H11. H11: THE DEVICE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION DID NOT IDENTIFY ANY ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. THE SAMPLE WAS OBSERVED TO BE CONTAMINATED WITH BLOOD. HENCE, NO ADDITIONAL TESTING COULD BE PERFORMED. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE OF THE CONDITION COULD NOT BE DETERMINED. HOWEVER, THIS COULD HAVE OCCURRED DUE TO A DAMAGED COMPONENT OR THE DEVICE COULD BE OUT OF SPECIFICATION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.