Additional information : the lot was manufactured may 25, 2018 - may 26, 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 revealed a leak between the spike port tubing and spike port connector.The reported condition was verified.The cause of the condition was not determined.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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