Qn#(b)(4).The customer returned an ars and introducer needle.Visual examination of the components did not reveal any defects or anomalies.The introducer needle was functionally tested with the returned ars per the instructions for use (ifu).The ifu states, "insert introducer needle or catheter/needle with attached syringe or arrow raulerson syringe (where provided) into vein and aspirate." the introducer needle was attached to the ars.The hub of the introducer needle fit snugly on the nose of the ars syringe.The returned 18 ga introducer needle felt secure on the ars and were able to draw and aspirate water with no issues.The connection between the syringe and the needle was compared with another ars syringe and introducer needle from lab inventory.The returned ars syringe was tested with a lab inventory needle, and the returned needle was tested with a lab inventory ars syringe.No differences were detected.The hub of the 18 ga introducer needle was tested with the male luer gage and was within the specified range.This indicates that the luer conforms to iso 594-1:1986.A device history record review was performed, and no relevant findings were identified.The ifu states, "insert introducer needle or catheter/needle with attached syringe or arrow raulerson syringe (where provided) into vein and aspirate." the complaint of syringe/needle connection not secure was not able to be confirmed by a complaint investigation of the returned sample.The 18 ga introducer needle and ars met all relevant functional testing.A device history record review was performed, and no relevant findings were identified.Based on the product returned, no problem was found on the sample.Teleflex will continue to monitor and trend on complaints of this nature.
|