CLEARLINK

Additional Manufacturer Narrative

SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED THAT THE OUTSIDE HUB OF A CLEARLINK SYSTEM STRAIGHT TYPE BLOOD SET DISCONNECTED FROM THE MAIN LINE. THIS WAS OBSERVED DURING BLOOD TRANSFUSION. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: D4: EXPIRATION DATE (UPDATE THE NULL VALUE TO N/A), H4, H6 (UPDATE CODES), H11. H11: THE ACTUAL DEVICE WAS NOT AVAILABLE; HOWEVER, TWO PHOTOGRAPHS OF THE SAMPLE WERE PROVIDED FOR EVALUATION. A VISUAL INSPECTION OF THE PHOTOGRAPHS OBSERVED A DAMAGED COLLAR IN THE TWO PIECE LUER BODY LOCK ASSEMBLY. THE REPORTED CONDITION WAS VERIFIED AS DAMAGE. HOWEVER, THE CAUSE OF THE CONDITION COULD NOT BE DETERMINED. 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.