Additional information was added to d9, h3, h4 and h6.H4: the lot was manufactured from april 23, 2020 - april 28, 2020.H10: the device was received for evaluation.A visual inspection was performed, and it was noted that there was a tear in the upper middle front side of the bag.Functional testing was performed which revealed a leak from affected area at the top middle area in front of the bag.Additional magnified inspection was performed which verified a tear/hole where the leak occurred.The reported condition was verified.The cause of the condition could not be determined; however, the possible causes of the tear/hole was due to compounding error, damage sustained during transport, or during customer handling.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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