H4: device manufactured on august 11, 2022- august 14, 2022.H10: the actual device was not available; however, a photograph of the sample was provided for evaluation.The photograph was of the secondary packaging; not of the actual bags.The photograph did show that liquid was evident at the bottom of the plastic bag from an unknown leak.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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