The device was returned and an evaluation is complete.Functional leak testing was performed by filling the bag with water and a leak was noted at the spike port cap.Visual inspection was performed and noted the fill port tubing was detached.The tubing was closed off and the bag was filled with tap water.There was a leak noted at the spike port cap.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The cause was not determined.This issue is being further investigated.Should additional relevant information become available, a supplemental report will be submitted.
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