(b)(4).The actual device was not returned; however, the customer provided a photo for evaluation.Visual inspection of the photo revealed two 18 ga introducer needles with their cannulas severely bent to the point of almost separating.A complete visual inspection could not be performed as no sample was returned for analysis.A device history record review was performed, and one relevant finding was found for the introducer needle.A non-conformance was initiated to address the issue of the needle becoming undocked from the holder during puncture.It cannot be determined if this damage is related to the complaint without the sample returned.The instructions for use (ifu) provided with this kit instructs the user, "insert introducer needle with attached arrow raulerson syringe into vein and aspirate." the complaint of a broken needle cannula was confirmed through examination of the customer supplied photo.Visual inspection of the photo revealed two introducer needles with their cannulas bent almost to the point of separation.A device history record review was performed , and one relevant finding was found for the introducer needle.It cannot be determined if this damage is related to the complaint without the sample returned.Without the device to evaluate, the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
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