CLEARLINK BLOOD RECIPIENT SET

Additional Manufacturer Narrative

CORRECTION TO D4: UNIQUE IDENTIFIER (UDI) # ADDITIONAL INFORMATION: D4(EXPIRATION DATE WAS FOUND TO BE IN NOVEMBER 2028.), D10: CONCOMITANT PRODUCT (1) (CONCOMITANT PRODUCT^ AND THERAPY DATE^ WERE UPDATED.), E4, H3, H4, H6, H11. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THE DEVICE WAS NOT RECEIVED FOR EVALUATION; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Additional Manufacturer Narrative

E1: INITIAL REPORTER FACILITY NAME: (B)(6). G1: DEVICE MANUFACTURER ADDRESS 1: (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED THAT A CLEARLINK SYSTEM Y-TYPE BLOOD/SOLUTION SET BROKE AT THE JUNCTURE BETWEEN THE HARD PLASTIC AND TUBING RESULTING IN SPILLED BLOOD. THIS ISSUE OCCURRED DURING THE ADMINISTRATION OF A BLOOD SETUP IN THE OPERATING ROOM. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.