H4: the lot was manufactured between august 9, 2023 - august 10, 2023.H10: the actual device was received for evaluation containing 45ml of fluid in the bladder.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.After the luer cap was removed, evidence of continuous flow of fluid was observed flowing out of the distal luer.A functional flow rate test was performed, the flow rates were found to be within the product specification range.During the flow test, evidence of continuous flow of fluid was observed flowing out of the distal luer.The reported condition was not verified.The device was determined to be 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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