H4: device manufacture date: october 14, 2021 - october 15, 2021.H10: the device was received containing 190 ml of fluid in the bladder.Visual inspection using the naked eye did not identify any abnormalities that could have contributed to the reported condition.A functional flow rate test was performed and the results were within the product specification range.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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