CLEARLINK

Additional Manufacturer Narrative

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 CLEARLINK Y-TYPE BLOOD/SOLUTION SET WITH STANDARD BLOOD FILTER EXPERIENCED A SEPARATION ISSUE. WHILE PRIMING THE SET FOR TRANSFUSION, THE HARD PLASTIC BETWEEN THE TUBING AND THE NEAR FILTER SNAPPED OFF. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

Additional Manufacturer Narrative

CORRECTION: B3, D4 EXPIRATION DATE (UPDATE TO N/A), D4 UDI # (REMOVE EXPIRATION DATE), D10. ADDITIONAL INFORMATION: D9, H3, H4, H6 (UPDATE CODES), H11. H11: THE DEVICE WAS RECEIVED FOR EVALUATION. A VISUAL INSPECTION WAS PERFORMED WHICH IDENTIFIED THE BLOOD FILTER CHAMBER WAS BROKEN AT THE BOTTOM CAP. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE OF THE CONDITION COULD NOT BE DETERMINED; HOWEVER, MAY BE DUE TO INCORRECT PRODUCT HANDLING BY THE USER. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.