Device manufacture date: the lot was manufactured between 12/02/2017 - 12/14/2017.The device was received for evaluation.The bottom right corner was cut where the customer likely drained the contents.Visual and magnified inspections were performed and revealed a tear/hole in the top seam of the returned sample.Functional testing was performed and leak was observed.The cause of the condition could not be determined.This issue is being further investigated.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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