H4: the device was manufactured from december 13, 2021 - december 14, 2021.H10: the actual devices were not available; however, photographs of the samples were provided for evaluation.The photographs were visually inspected which showed fluid inside the bladders which suggested under infusions 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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