The device was returned and an evaluation is complete.Functional leak testing was performed by filling the bag with water and a leak was noted at the top seam of the bag.Visual inspection was performed and noted a tear at the top seam, where the bag had leaked.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.This issue is being further investigated.Should additional relevant information become available, a supplemental report will be submitted.
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