Additional information: h3, h4, h6, h10.H4: the lot was manufactured between april 11-13, 2023.H10: the actual device was received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.Functional leak testing was performed, and no evidence of leaking was observed.Based on the evaluation result, the infusor device 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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