(b)(4).The lot 14f005 was manufactured june 5, 2014 - june 6, 2014.The device was received for evaluation.Visual inspection on the device (via the naked eye) noted fluid inside the package that contained the device.When the device was removed from the packaging, the cause of fluid inside the package was visually identified to be an untightened blue winged luer cap.A functional testing was performed by filling the device with green colored water.After filling the device with the green water solution, the blue winged luer cap was hand tightened by manually rotating the cap until the cap could no longer be rotated.The device was monitored until the next day; as a result there were no signs of leak 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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