The single-use device was received for evaluation.Visual inspection revealed fluid inside the bag that contained the device.When the device was removed from the bag, the cause of the fluid was found to be an untightened blue winged luer cap.A functional leak test was performed by filling the device with water and manually tightening the blue winged luer cap.During and after fill, no signs of a leak were observed from the device.The reported condition was not verified.The device was found to be conforming product.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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