The device was manufactured from may 13, 2019 - may 14, 2019.The actual device was discarded; however, a photograph of the sample was provided for evaluation.Visual inspection of the photograph was performed and a leak inside a bag that contained the device was identified; however the location of the leak was not determined.The reported condition was verified.The cause of the reported 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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