H4: the lot was manufactured between february 19, 2023 and february 20, 2023.H10: the actual device and a video were received for evaluation.A visual inspection of the video was performed which observed a leak between the spike port tubing and spike port connector.Visual inspection of the actual sample did not identify any abnormalities that could have contributed to the reported condition.Functional leak testing on the actual sample was performed with tap water and a leak was identified from the spike port bonding area.The reported condition was verified.The cause of the condition could not be determined; however, is most likely due to inadequate or lack of cyclohexanone applied to the spike port cap tube when it was inserted to the spike port during the manufacturing process.A nonconformance has been opened to address this issue.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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