Additional information: d9, h3, h4, h6, h11.H11: the actual device and a video of the sample was provided for evaluation.Visual inspection of the video observed a leak at the spike port bonding area.Visual inspection of returned sample did not identify any abnormalities that could have contributed to the reported condition.Functional leak testing of actual sample was performed 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 being applied to the spike port connector when it was inserted into the spike port during manufacturing.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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