The lot was manufactured from may 11, 2020 - may 12, 2020.The device was received for evaluation.The top left corner of the bag was cut where the customer likely drained the contents.Unaided visual inspection was performed which observed a small tear at the lower right side edge of the bag.A functional testing was performed which revealed a leak from the same area.Additional magnified inspection verified a tear/hole where the leak occurred.The reported condition 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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