The lot was manufactured from august 04, 2018 - august 05, 2018.The device was received for evaluation.Visual inspection was performed which 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 cap from the spike port.The reported condition was verified.The cause of the condition could not be determined.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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