CLEARLINK BLOOD RECIPIENT SET

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: H4: THE LOT WAS MANUFACTURED MARCH 2024. H11: THE ACTUAL DEVICE WAS NOT AVAILABLE; HOWEVER, A PHOTOGRAPH OF THE SAMPLE WAS PROVIDED FOR EVALUATION. VISUAL INSPECTION OF THE PHOTOGRAPH SHOWED A CRACK AT THE LEVEL OF THE CAP. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE OF THE CONDITION COULD NOT BE DETERMINED. ADDITIONALLY, RETENTION SAMPLES WERE VISUALLY INSPECTED AND NO OBVIOUS ISSUE/DAMAGE WERE DETECTED; THE SAMPLES WERE CONFORMING PER PRODUCT SPECIFICATIONS. THE RETENTION SAMPLES WERE ALSO LEAK TESTED UNDER WATER AND NO LEAKS WERE OBSERVED. THE REPORTED CONDITION WAS NOT VERIFIED ON THE RETENTION SAMPLES. 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.

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 CAP (LUER PLUG) OF A BLOOD/SOLUTION ANAESTHESIA/PCA INFUSION SET WAS DIFFICULT TO DISCONNECT AND THE "ATTACHMENT" (LUER PLUG) BROKE; THE CAP WAS DAMAGED (CRACKED) AT THE DISTAL END OF THE SIDE ARM. THE ISSUE WAS NOTICED DURING USE. THE SET WAS REPLACED TO RESOLVE THE EVENT. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.