(b)(4).The device history record was reviewed and no issue that could have contributed to the reported failure was noted.The device was manufactured according to release specification.The sample was returned for evaluation.A visual exam was performed and there were no defects observed.Functional testing was also performed on the returned sample and syringe, and it was found that the cuff would inflate and deflate.It was noticed that more force was needed to insert the syringe into the cpv.The size of the outer cylinder was tested with a gauge and it was found that it was within specification; however, it was at the lower range of the required tolerance.The manufacturer reports that a new mold was introduced to production in october 2016.In (b)(6) 2016, it was identified through 100% functional testing that it may not be as easy to insert the syringe into the female conical fitting (luer) of the cuff pilot produced on this new mold.The device passed the required release criteria.At this time teleflex removed the new mold and reverted to the original mold.Upon investigation, it was found that the drawing stipulating the inner diameter of the female conical fitting (luer) for the cuff pilot was not sufficiently clear with respect to the tolerance range.This allowed for devices to be manufactured closer to the lower range of the required tolerance, however the device was manufactured within tolerance therefore the complaint could not be confirmed.At this lower range, it may not be as easy for the user to insert the syringe into the female conical fitting (luer).
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