Additional information was added to d10, h3, h4 and h6.H4: device manufactured between february 11, 2020 to february 12, 2020.H10: the device was received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.Functional testing was performed which revealed a leak at the spike port bonding area.The reported condition was verified.The cause was not determined; however the most likely cause was due to inadequate or lack of cyclohexanone being applied to the cap tubing when it was inserted to 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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