H4: the lot was manufactured from november 01, 2022 - november 03, 2022.H10: the actual device was not available; however, a photograph of the sample was provided for evaluation.The photograph was reviewed which identified a leak from the blue winged cap due to a damaged blue winged cap.Indentation marks from the manufacturing sealer equipment were observed on the damaged area of the cap.The reported condition was verified.The cause of the condition was related to a manufacturing issue.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.
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