Additional information was received for d9, h3, h4, h6, and h10.H4: device manufacture date: the lot was manufactured from march 1, 2023 to march 2, 2023.H10: the device was received for evaluation.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 on the sample, and the flow rates were found to be within the product specification range.Based on the evaluation result, the folfusor sample 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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