H4: the lot was manufactured from october 11, 2021 ¿ october 12, 2021.H10: the device was received for evaluation.Unaided visual inspection was performed which observed a tear at the lower right front side edge area of the bag.Functional testing was performed which revealed a leak in the affected area.Additional magnified inspection verified a tear/hole where the leak 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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