H4: the lot was manufactured june 13, 2022 to june 14, 2022.H10: the actual device was not available; however, a photograph of the sample was provided for evaluation.A visual inspection of the photograph showed fluid inside the bladder, which suggested a no flow issue may have occurred.Therefore, the reported condition was verified.The cause of the condition could not be determined from the photograph.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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