Qn #(b)(4).The customer returned the proximal luer hub of a 3 lumen cvc and the swg for analysis.The proximal extension line was not returned for analysis.The proximal luer hub will be analyzed as part of this investigation.Visual analysis revealed that the proximal luer hub (white hub) had separated from the assembly; however, the proximal extension line was not returned for analysis.Remains of the extension line were found inside the luer hub.The customer did not return the rest of the catheter.The inner diameter of the proximal lumen measured to be 1.4732 mm which is within specifications of 1.42-1.50 mm per product drawing.The returned catheter luer hub was not able to be functionally tested due to the damage and the lack of the entire catheter returned for analysis.A device history record review was performed with no relevant findings.The ifu provided with this kit warns the user, "do not apply excessive force in placing or removing catheter or guidewire.Excessive force can cause component damage or breakage.If damage is suspected or withdrawal cannot be easily accomplished, radiographic visualization should be obtained and further consultation requested.Do not secure, staple and/or suture directly to outside diameter of catheter body or extension lines to reduce risk of cutting or damaging the catheter or impeding catheter flow.Secure only at indicated stabilization locations." the customer report of an extension line/luer hub separation was confirmed by complaint investigation of the returned sample.The proximal luer was separated and contained remnants of the extrusion within the hub.However, the proximal extension line was not returned for analysis.The sample passed all relevant dimensional inspections, and a device history record review was performed with no relevant findings.Based on the sample received, a root cause could not be determined without the rest of the catheter returned for analysis.Teleflex will continue to monitor and trend on complaints of this nature.
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