Qn# (b)(4).The customer returned one ars and catheter/needle assembly for evaluation.Visual inspection did not reveal any defects or anomalies.There were no cracks observed in the needle hub.The ars tip appeared normal.The catheter/needle assembly was functionally tested with the returned ars per the instructions for use (ifu).The ifu states, "insert introducer needle with attached arrow raulerson syringe (where provided) into vein and aspirate.Catheter/needle may be used in the standard manner as alternative to introducer needle.If catheter/needle is used, arrow raulerson syringe will function as a standard syringe , but will not pass spring-wire guide." the returned needle felt secure on the ars and was able to draw and aspirate water with no issues.The hub of the catheter/needle assembly was tested with the male luer gage and was within the specified range.This indicates that the luer conforms to iso 594-1:1986.The tip of the ars was tested with the female luer gage and was within the specified range.This indicates that the ars tip conforms to iso 594-1:1986.A device history record review was performed, and no relevant findings were identified.The complaint of syringe/needle connection not secure was not able to be confirmed by a complaint investigation of the returned sample.Both the catheter/needle assembly 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.
|