H4: the lot was manufactured from june 13, 2020 - june 15, 2020.H10: the device was received for evaluation.Visual inspection was performed which identified physical damage (small gouge) to the fill port.Functional testing with tap water did not identify any leak.The reported leak condition was not verified; however damage was identified.The cause of the damage 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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