H4: the lot was manufactured between may 20, 2023 ¿ may 21, 2023.The device was received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported leak.Functional testing was performed, and a leak was observed from the administration port 2 bonding area.The reported condition was verified.The direct cause of the leak could not be determined; however, it is likely due to incorrect bonding from inadequate or lack of cyclohexanone applied to the spike port cab tube when it was inserted into the spike port during the manufacturing process.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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