(b)(4).This lot was manufactured april 20, 2014 to april 21, 2014.Evaluation summary: visual inspection noted fluid in the bag that contained the unit.The leak was coming from an untightened blue winged luer cap.A functional test was performed and the blue winged luer cap was hand tightened.The next day there were no signs of a leak at the luer cap.The reported condition could not be 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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