Additional information : the lot was manufactured between april 14, 2018 - april 15, 2018.The actual device was not available; however, a photograph of the sample was provided for evaluation.Photo inspection revealed the reported problem of leak.Functional testing was not performed due to the nature of the sample.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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