CLEARLINK

Additional Manufacturer Narrative

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 A CLEARLINK SYSTEM Y-TYPE BLOOD/SOLUTION SET TUBING BROKE OFF AT SPIKE SITE. THIS OCCURRED WHILE HANGING THE BLOOD TRANSFUSION ONCE BAG WAS SPIKED DURING INFUSION SETUP. 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 A2, A3A, A5, A6, B5, D10, E4, G2 (ADD SOURCE), H4, F10/H6: MEDICAL DEVICE PROBLEM CODES (ADD CODE), H6, H10, H11. B5: THE TUBING BREAKING OFF AT THE SPIKE SITE RESULTED IN MINIMAL BLOOD LOSS FROM THE BLOOD BAG. 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.