Qn#(b)(4).The customer returned a cvc kit lidstock with one catheter, introducer needle, and box clamp assembly.Visual inspection of the spring wire guide (swg) could not be performed as the guide wire was not returned for analysis.Visual inspection of the catheter revealed no obvious defects.The length of the catheter body returned was 218 mm with is within the specifications of 207-227 mm from product drawing.A lab inventory swg was advanced through the returned catheter with no resistance.Additional testing could not be performed on the swg as no sample was returned for analysis.The catheter was flushed with water to confirm no blockage.Water passes through all extension lines except the proximal (white).A device history record review was performed on the swg and catheter and no relevant findings were identified.The ifu provided with this kit warns the user, "do not apply undue force on guidewire to reduce risk of possible breakage." complaint testing could not be performed on the swg as the component was not returned for analysis.The returned catheter met all relevant dimensional and functional testing.A device history record review was performed on both the swg and catheter and no relevant findings were identified.Without the swg to evaluate, the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
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