H4: the lot was manufactured december 20, 2022 to december 21, 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 that the device had not infused.The reported condition was verified.Due to the nature of the sample, no additional tests were performed.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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