The device was manufactured from march 28, 2019 - march 30, 2019.The actual device was received for evaluation.Upon receipt, a visual inspection on the unit with the naked eye noted fluid inside the bag that contained the unit.When the unit was removed from the bag, the cause of fluid inside the bag was found to be an untightened blue winged luer cap.Functional testing was performed by filling the device with green colored water.After fill, the blue winged luer cap was hand tightened.The sample was monitored until the next day and no signs of leak were observed.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.Should additional relevant information become available, a supplemental report will be submitted.
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