CLEARLINK CONTINU-FLO BLOOD RECIPIENT SET

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 LUER LOCK OF A CONTINU-FLO BLOOD/SOLN SET SEPARATED FROM THE TUBING. THE END OF THE LINE WAS OPEN. THIS WAS OBSERVED WHEN PRIMING THE LINE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

Additional Manufacturer Narrative

CORRECTION MADE TO G1: ADDITIONAL INFORMATION WAS ADDED TO H4, H6, AND H11: H4: THE LOT WAS MANUFACTURED APRIL 2024. H11: THE ACTUAL DEVICE WAS NOT AVAILABLE; HOWEVER, RETAINED SAMPLES WERE EVALUATED. VISUAL INSPECTION DID NOT IDENTIFY ANY ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. A LEAK TEST UNDER WATER WAS PERFORMED, AND NO LEAKS WERE OBSERVED. THE REPORTED CONDITION WAS NOT VERIFIED. 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.