(b)(4).Six capd sets (5 opened samples and 1 unused companion sample) were returned for evaluation.No abnormalities were identified during visual inspections of the sets.All devices passed an underwater leak test, a clear passage test, and a clamp functional test.Furthermore, each sample was able to connect to a test transfer set with no issues noted.A batch review of the associated lot number was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The reported connection issue was unable to be verified during sample analysis.Should additional relevant information become available, a supplemental report will be submitted.
|