H4: the lot was manufactured between april 11-13, 2023.H10: the actual device was received for evaluation with 59ml of fluid in the bladder.A visual inspection was performed which did not identify any abnormalities that could have contributed to the reported condition.Removal of luer cap showed evidence of continuous flow of fluid out of the distal luer.A functional flow rate test was performed, and the results were found to be within the product specification range.The reported condition was not verified.The device was found 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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