(b)(6).The lot was manufactured october 01, 2021 - october 02, 2021.The device was received for evaluation.Visual inspection was performed and the blue winged cap was observed separated from the distal luer of the device.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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