Qn#(b)(4).The customer returned one arrow raulerson syringe (ars), an introducer needle, swg, dilator, s-l catheter and lidstock for evaluation.Visual examination of the ars did not reveal any anomalies or defects.After the ars failed the vacuum leak functional test, the handle was broken to examine the valves inside.The valve mechanism consists of two bi-lateral valves and a spacer.A small puncture hole was observed in the center of both valve pieces.There was evidence of the slits in the center of the valves.No defects or anomalies were observed in any of the other returned components.A vacuum leak test was performed on the samples per inspection procedure.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 it did not snap back into a position = 1cc from the starting position.The ars passes the test if the plunger returns to a position = 1cc; therefore, the sample failed functional inspection.A push leak test was also performed on the ars per inspection procedure.With the plunger body fully out of the barrel, the tip of the ars was occluded, and the plunger was pushed into the barrel.Resistance was initially felt, but the plunger body was able to move to the bottom of the syringe; therefore, the sample failed the push leak test.A device history record review was performed, and no relevant findings were identified.The issue of the ars leaking was confirmed during functional testing of the returned sample.The returned syringe failed both the vacuum testing and the push testing.Examination of the plunger seal and the valve revealed small puncture hole in both of the valve halves.A device history record review did not reveal any relevant findings.A capa has been initiated to further investigate this complaint issue and has determined a root cause of manufacturing; corrective actions have not yet been implemented.Teleflex will continue to monitor and trend reports of this nature.
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