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 THERE WAS A CUT IN THE TUBING OF TWO (2) ADMINISTRATION SET FOR BLOOD AND BLOOD COMPONENTS. THE CUT TUBING WAS OBSERVED WHEN OPENING THE PACKAGING PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION WAS ADDED TO D9, H3, H4, H6, H11. H4: THE LOT WAS MANUFACTURED IN APRIL 2024. H11: TWO (02) ACTUAL DEVICES WERE RECEIVED FOR EVALUATION. DURING VISUAL INSPECTION THE FIRST UNIT HAD A DAMAGED TUBE (CUT IN THE TUBE). HOWEVER, THE SECOND DEVICE DID NOT SHOW ANY ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. RETENTION SAMPLES ALSO UNDERWENT VISUAL INSPECTION AND DID NOT SHOW ANY ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. ADDITIONALLY, THE SECOND DEVICE AND RETENTION SAMPLES UNDERWENT GRAVITY TESTING IN THE LABORATORY; THEN LEAK TESTED UNDER WATER VIA A CALIBRATED PROVASET AND NO ISSUES WERE NOTED. THE REPORTED CONDITION WAS VERIFIED IN THE FIRST UNIT ONLY. THE CAUSE OF THE CONDITION WAS DETERMINED TO BE AN IMPROPER COILING BY THE PACKING MACHINE DURING THE SEALING PROCESS. THE REPORTED CONDITION WAS NOT VERIFIED IN THE SECOND SET AND 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.