Therapy dates - the event was reported to have occurred on an unknown date in (b)(6) 2016.(b)(6).The device was received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.Simulated use testing was performed by connecting the device to a male luer syringe and to the female connection of an in-house stopcock, and allowing fluid to flow through the setup.No leaks were observed during simulated use testing.Pressure testing was also performed with no issues noted.The device was found to operate per specification.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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