H4: device manufacture date: the lot was manufactured from february 27, 2023 to march 2, 2023.H10: the actual device was received for evaluation.The unit contained 236 ml of fluid in the bladder.A 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 was observed.A functional flow rate test was performed, and the flow rates were found to be within the product specification range.The reported condition was not verified.The sample 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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