H4: the lot was manufactured april 11-13, 2023.H10: the device was received for evaluation with no fluid in the bladder.Visual inspection did not identify any abnormalities that could have contributed to the reported no flow condition.A functional flow rate test was performed, and the flow rates of the device were found to be within specification.During the flow test, evidence of continuous flow of fluid was observed flowing out of the distal luer.The reported no flow 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.
|