H4: the lot was manufactured january 22, 2019 to january 23, 2019.H10: the device was received for evaluation.The unit contained 201ml fluid in the bladder.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.A functional flow rate test was performed and the flow rate of the device was found to be within specification.The reported condition was not verified.The device was determined to be a conforming product.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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