Qn#(b)(4).The customer returned one, opened cvc kit for analysis.No definite signs of use in the form of biomaterial were observed on any of the returned components.Visual analysis of the syringe revealed no obvious defects or anomalies.The msk graphic for the finished good ((b)(6) rev72) was reviewed.The returned syringe matches what is pictured.The 5ml syringe was functionally tested per the instructions for use (ifu) provided with this kit, which instructs the user, "insert introducer needle or catheter/needle with attached syringe or arrow raulerson syringe (where provided) into vein and aspirate".The syringe was connected to the returned catheter over needle and was able to draw and aspirate water as intended.The module requirement document for standard syringes ((b)(4) rev 07) was reviewed to determine requirements for air/water leakage.Section 7.3 outlines the performance testing for air/water leakage, which states, "when tested in accordance to annex d of bs en iso 7886-1, there shall be no leakage of water past the plunger stopper or seal(s).Small droplets between the seals are not considered failure".With the plunger body at the bottom of the syringe, the tip of the syringe was occluded, and the plunger was pulled back until it stopped.With the tip of the syringe still occluded, the plunger was released and did snap back into a position = 1cc from the starting position.No air leaks past the plunger stopper.Likewise, the plunger stopper did not become detached from the plunger.A device history record review was performed, and a potentially relevant finding was identified.A non-conformance was initiated to address the issue of "product does not correspond to the drawing".However, based on the returned sample, it has been concluded that this is not relevant to this investigation.The msk product drawing of the reported finished good.It is confirmed that the returned syringe matches what is pictured.The ifu provided with the kit informs the user, "ensure catheter patency prior to use.Do not use syringes smaller than 10 ml (a fluid filled 1 ml syringe can exceed 300 psi) to reduce risk of intraluminal leakage or catheter rupture".The customer report of a leaking injection syringe could not be confirmed through investigation of the returned sample.The syringe passed all relevant functional testing when tested in accordance with annex d of bs en iso 7886-1.Based on the customer description and sample received, no problem was found.Teleflex will continue to monitor and trend on reports of this nature.
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