H4: the lot was manufactured from may 17, 2022 - may 18, 2022.H10: two (2) companion samples were received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.All components were correctly placed and according to specifications.A functional testing was performed including clear passage and pressure testing; and the results were satisfactory.Priming was performed at the set with a bag of sterile water and no defect was observed.Autopsy was performed in the six y-site clearlink and no defect was 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.
|