(b)(4).The customer returned one luer hub for investigation.The catheter was not returned.Visual inspection revealed the distal luer hub separated from its extension line.The point of separation is unknown as the catheter was not returned.Remains of the extension line were visible inside the luer hub.The inner diameter of the distal lumen inside the luer hub measured to be 1.4732mm, which is within specifications of 1.42 - 1.50mm per product drawing.Dimensional inspection of the remainder of the catheter extension line could not be performed as it was not returned for evaluation.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 instructions for use (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." the customer report of an extension line/luer hub separation was confirmed by complaint investigation of the returned sample.Remains of the extension line were observed on the separated luer hub.The probable root cause of this event could not be determined without the catheter returned for analysis.Teleflex will continue to monitor and trend for complaints of this nature.
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