H4: the lot was manufactured between february 19, 2023 and february 20, 2023.H11: the actual device and a video of the sample were provided for evaluation.Visual inspection of the actual sample was performed which did not identify any abnormlities that could have contributed to the condition.However, visual inspection of the video observed a leak at the spike port bonding area.A functional leak test was performed using tap water and a leak was observed from the spike 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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