Additional information was added to d10, h3, h4 and h6.H4: the lot was manufactured from march 20, 2020 - march 21, 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 between the spike port tubing and the spike port bonding area.The reported condition was verified.The cause of the condition was not determined; however, the most likely cause was due to inadequate or lack of cyclohexanone being applied to the spike port connector when it was inserted to the spike port tubing.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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