Additional information was added to h3, h4, h6 and h10.H4: device manufactured between march 2, 2020 to march 4, 2020.H10: the device was received for evaluation in its original unopened package.Visual inspection was done which observed the blue winged luer cap had separated from the flow restrictor.The reported condition was verified.The cause of the condition was due to a manufacturing related issue.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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