H4: device manufacture date: the lot was manufactured from june 30, 2022 to july 1, 2022.H10: the actual device was received for evaluation.A visual inspection noted a leak coming out at the junction of the tubing and the module post.Examination of the leak area revealed the cause of the leak was due to a surface cut located on the tubing.The reported condition of leak was verified.The cause of the condition could not be determined.A functional flow rate test was also performed on the unit and the results were found to be within the product specification range.Evidence of continuous flow of fluid was observed during the flow test.The reported condition of ¿did not infuse¿ was not verified during the sample evaluation.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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