The device was manufactured from march 22, 2019 - march 25, 2019.Two (2) devices were received for evaluation.During visual inspection via the naked eye, fluid was observed inside the bag that contained the unit.When the unit was removed from the bag, the cause of fluid inside the bag was visually identified to be untightened blue winged luer cap.Functional testing was performed, the blue winged luer cap was hand tightened by manually rotating the cap until the cap could no longer be rotated.The unit was monitored for twenty-four hours.No signs of leak were observed at the blue winged luer cap of either device.The reported condition was not verified.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.A nonconformance has been opened to address this issue.Should additional relevant information become available, a supplemental report will be submitted.
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