Device manufactured between november 30, 2018 to december 03, 2018.The actual device was not available; however, a photograph of the sample was provided for evaluation.The returned photograph was inspected, and it was determined that there was evidence of a leak from the bag.The reported condition was verified.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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