H4: the lot was manufactured from may 27, 2020 - may 28, 2020.H10: the device was received for evaluation.Unaided visual inspection was performed did not identify any abnormalities that could have contributed to the reported condition.Functional testing was performed which revealed a leak at the upper left front side of the bag.The reported condition of leak was verified.The cause of the condition was not 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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