(b)(4).The actual sample was not returned; therefore ten pieces of the same catalog number were taken from current production at the manufacturing facility to test the reported defect.All ten samples passed visual and leak testing.In addition, a plug test gauge and ring gauge test were conducted on the ten production samples to spot if the diameter of humid-flo connector which connects to the ventilator circuit or patient is out of specification.Both sides met the specification.A device history record review was performed and no relevant findings were identified.Without the actual device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the a vailable information.Teleflex will continue to monitor and trend for reports of this nature.
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