The lot was manufactured from june 01, 2019 - june 04, 2019.The device was received for evaluation.Visual inspection was performed and a tear at the lower left edge of the bag was identified.Functional testing was performed and a leak at the lower left edge of the bag was identified.During magnified inspection a tear/hole in the lower left edge of the bag was observed where the leak was verified.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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