Additional information was added to d4 expiration and udi #, d9, h3, h4 and h6.H4: the lot was manufactured from september 25, 2020 - september 28, 2020.H10: the device was received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.Functional testing was performed with tap water which revealed a leak from the top left side seam in back of the bag.Additional magnified inspection verified a small tear/hole where the leak occurred.The reported condition was verified.The cause of the tear/hole 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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