H4: the lot was manufactured between may 3, 2023 and may 5, 2023.H11: the device was received for evaluation with 97ml of fluid in the bladder.A visual inspection was performed which 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, and the flow rates were found to be within the product specification.During the flow test, evidence of continuous flow of fluid was observed flowing out of the distal luer.Based on the evaluation result, the infusor unit was determined to be conforming product.The reported condition was not verified.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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