(b)(4).The customer returned one catheter assembly from an endurance device.No other components from the endurance device were returned.Signs of use in the form of biological material were observed.Visual analysis did not reveal any defects or anomalies of any kind.A lab inventory 10 ml syringe was attached to the returned catheter side arm and flushed.Water was observed exiting out of the distal tip of the catheter, which is the intended function of the device.The distal end of the catheter was then occluded, and water was pressurized through the catheter assembly.No leaks were observed.Performed per ifu statement "flush catheter using a 10 ml syringe filled with normal saline for injection".Per the leak requirements listed in amrq d001357, "the catheter shall not leak liquid in accordance with the method given in annex c of bs en iso 10555-1".The distal end of the catheter body was occluded.The side arm was then attached to the leak tester and pressurized to 300kpa for 30 seconds.No leaks out of the valves or any portion of the catheter body were observed.A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit informs the user, "ensure catheter patency prior to pressure injection to reduce risk of catheter failure and/or patient complications.Inability to obtain brisk blood return or to flush easily indicates a possible problem with the catheter and catheter should not be used".The amrq for endurance catheters was reviewed as part of this complaint investigation.The report of a leaking endurance catheter was not able to be confirmed through complaint investigation.Visual and functional analysis did not reveal any defects or anomalies of any kind.The catheter was leaked tested in accordance with iso 10555-1 and no leaks were observed.A device history record review did not reveal any relevant findings.Based on the customer report and the sample received, no problem was found with the returned device.Teleflex will continue to monitor and trend for reports of this nature.
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