Qn# (b)(4).The customer returned an opened cvc kit containing multiple components, including one arrow raulerson syringe (ars), an introducer needle, a guide wire, and the product lidstock for analysis.Signs of use in the form of biological material were observed on the ars.Visual examination of the ars did not reveal any anomalies or defects.The returned sample was functionally tested using the returned 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 draw and aspirate water with and without the introducer needle.The module requirement document for raulerson syringes was reviewed to determine requirements for air/water leakage.The document notes a deviation from iso 7886-1: "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 in order 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 until it stopped.With the tip of the ars still occluded, the plunger was released and did snap back into a position = 1cc from the starting position.Therefore, the internal valves of the ars are functioning as intended.A device history record review was performed, and a relevant finding was identified.A non-conformance was initiated for lot# 71c21a1218 to address the issue of a leaking syringe.The issue of ars leaking could not be confirmed during functional testing of the returned sample.The ars was able to draw and aspirate water with and without an introducer needle, and passed all relevant additional testing.No problem was found with the returned device.Teleflex will continue to monitor and trend for reports of this nature.
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