H4: the device was manufactured from april 27, 2022 - april 29, 2022.H10: the actual device was not available; however, a photograph of the sample was provided for evaluation.The photograph was visually inspected and did not show evidence of ruptured bladder.The photo showed images of fluid inside the green bag which suggested a leak may have occurred.The reported condition was verified.The cause of the condition could not be determined.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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