(b)(4).The customer returned one 4-lumen cvc for analysis.Signs-of-use were observed inside the extension lines.Visual analysis revealed that the proximal extension line contained a large hole directly adjacent to the luer hub.Microscopic examination confirmed the damage.The proximal extension line inner diameter measured 1.448mm, which is within the specification limits of 1.42mm-1.50mm per the proximal extension line extrusion graphic.The proximal extension line outer diameter measured 2.16mm, which is within the specification limits of 2.13mm-2.21mm per the proximal extension line extrusion graphic.All four lumens were initially flushed using a water-filled lab inventory syringe to ensure no blockages were present.The distal end of the catheter was then clamped, and each lumen was pressurized using a water-filled lab inventory syringe.When the proximal line was pressurized, a small leak was detected near the luer hub of the extension line.No leaks were detected in the other lines.A manual tug test confirmed all four luers were fully secured to their respective extension lines.The customer did not provide a lot number; therefore, a device history record review was performed based upon a lot number from the sales history data of the customer.No relevant findings were identified.The ifu provided with the kit informs 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".The customer report of an extension line leak was confirmed by functional and visual inspection of the returned sample.The proximal extension line contained a small hole adjacent to the luer.A device history record review was performed based on sales history, and no relevant findings were identified.A capa has previously been initiated due to an increasing trend of cvc extension line leaks and separations.The root cause of this issue has not yet been determined.Teleflex will continue to monitor and trend reports of this nature.
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