(b)(4).The customer report of a foreign material observed was confirmed by investigation of the returned sample.The customer supplied photos and video confirmed that there were foreign particulates coming from inside the arrow raulerson syringe (ars) valve.The customer returned an opened cvc kit including an introducer needle, guide wire assembly, and arrow raulerson syringe (ars) for evaluation.It was observed that the guide wire was advanced through the ars and there was a kink where the guide wire meets the proximal opening of the ars.The customer was contacted and responded that they were not aware of the kink.Visual inspection revealed that there were no signs of use observed.Further visual analysis of the guide wire assembly and ars revealed foreign particulate on the straightener tube and within the ars handle.Microscopic examination confirmed the foreign material inside the ars handle and straightener tube.Further analysis revealed that there was a hole in the internal valves of the ars.As per r & d engineering and manufacturing unit, a positive confirmation of the material could not be made based on the appearance of the substance and the small quantity p resent within the straightener tube and ars handle.Additionally, it could not be confirmed when the particulate was introduced into the kit.A device history record review was performed, and no relevant findings were identified.Based on the appearance of the sub stance and the small quantity present within the components, a positive confirmation of the material could not be made.Additionally, it cannot be confirmed when the particulate was introduced into the kit.Based on the sample received, comments from r & d, and the complaint investigation, the potential root cause cannot be determined.Teleflex will continue to monitor and trend for complaints of this nature.
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