Additional information: d9, h3, h4, h6, h10.H4: the lot was manufactured between september 19, 2019 to september 20, 2019.H10: the device was received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.The sample was gravity tested then leak tested under water with no issues noted.The reported condition was not verified.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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