(b)(4).The customer returned the product lidstock for evaluation.None of the components from the kit were returned.Visual examination of the lidstock confirmed the part number and lot number matched what was reported by the customer.A device history record review was performed on the catheter and no relevant manufacturing issues were identified.The instructions-for-use (ifu) provided with this product describes suggested techniques for catheter insertion to mitigate risk of damaging the catheter.The ifu also contains the warning "alcohol and acetone can weaken the structure of polyurethane material.Therefore, care should be taken when instilling drugs containing alcohol or when using high concentration of alcohol or acetone when performing routine catheter care and maintenance." the customer report of a damaged catheter tip could not be confirmed.Only the product lidstock was returned, none of the components were returned for evaluation.A device history record was performed and no relevant manufacturing issues were identified.Without the actual device 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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