BLOOD RECIPIENT SET

Description of Event or Problem

IT WAS REPORTED THAT A BLOOD RECIPIENT SET LEAKED FROM AN UNSPECIFIED LOCATION. THIS WAS OBSERVED DURING USE. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

Additional Manufacturer Narrative

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

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: H4, H6, H11. H11: THE ACTUAL DEVICE WAS NOT AVAILABLE; HOWEVER, COMPANION SAMPLES AND RETAINED SAMPLES WERE EVALUATED. VISUAL INSPECTION OF THE SAMPLES DID NOT IDENTIFY ANY ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. THE INTEGRITY TEST (UNDERWATER LEAK TEST) WAS PERFORMED ON THE COMPANION SAMPLES, AND NO LEAK WAS OBSERVED. VISUAL INSPECTION OF THE RETENTION SAMPLES DID NOT IDENTIFY ANY DEFECTS. THE REPORTED CONDITION WAS NOT VERIFIED IN EITHER THE COMPANION OR 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.