Additional information was added to h3, h4 and h6.H4: device manufactured between november 06, 2019 to november 07, 2019.H10: the device was received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.A functional test was performed which revealed a leak at the spike port bonding area between the spike port tubing and the spike port connector.The reported condition was verified.The cause was not determined, however, a likely cause of inadequate or lack of cyclohexanone being applied to the cap tubing when it was inserted to the spike port during the manufacturing process was noted.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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