(b)(4).The issue of ars leaking could not be confirmed during functional testing of the returned sample.The customer returned one arrow ra ulerson syringe (ars) for evaluation.No definite signs-of-use in the form of biological material were observed on the returned components.Visual examination of the ars did not reveal any anomalies or defects.The returned sample was functionally tested using a lab inventory 18ga introducer needle in accordance with the instructions-for-use provided with this kit.The ifu states, "insert introducer needle or catheter/needle with attached syringe or arrow raulerson syringe (where provided) into vein and aspirate." the ars was able to successfully draw and aspirate water with and without the introducer needle attached.The module requirement document for raulerson syringes was reviewed to determine requirements for air/water leakage.The document noted a deviation from iso: "the freedom of air and liquid leakage past the piston requirement is design restrictive and is intended for an injection-intended syringe, not the ars.The opening in the center of the piston that allows passage of the inner cannula prohibits the ars from meeting the pressure and vacuum requirements as dictated by the standard.However, because the intended use of the ars is to allow aspiration of blood to ensure venous placement of the introducer needle and to aid in the insertion of the spring wire guide, the leakage requirements of a standard syringe are not applicable to the ars." a vacuum test was performed on the ars syringes to verify that the internal valves within the plunger body were intact.With the plunger body at the bottom of the syringe, the tip of the ars was occluded, and the plunger was pulled back.With the tip of the ars still occluded, the plunger was released and did snap back.Therefore, the internal valves of the ars were functioning as intended.A device history record review was performed, and no relevant findings were identified.No problem was found with the returned device.Teleflex will continue to monitor and trend for reports of this nature.
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