Additional information: the lot was manufactured august 24, 2018 - august 25, 2018.The device was received for evaluation.Visual inspection was performed and revealed that the blue winged luer cap had separated from the distal luer.The reported condition was verified.The cause of the condition could not be determined.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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