The lot was manufactured between june 20, 2018 and june 21, 2018.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 and a leak was observed at the spike port cap.The reported condition was verified.The cause of the reported condition was undetermined.This issue is being further investigated.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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