(b)(4).The customer provided one photo for analysis.The photo shows a kinked guide wire; however, the guide wire assembly was not pictured.The customer also returned an opened cvc kit including a 3-lumen catheter, 18ga introducer needle, and dilator for analysis.The guide wire was not returned.Visual analysis of the returned kit and its components did not reveal any defects or anomalies.Visual inspection of the guide wire could not be performed as the guide wire was not returned.A device history record review was performed and no relevant manufacturing issues were identified.The instructions-for-use (ifu) provided with this product warns the user, "do not use if package is damaged.".The report that the guide wire kinked during use was confirmed through visual analysis of the customer supplied photo.The customer photo shows a kinked guide wire; however, the guide wire was not returned.A device history record review did not identify any manufacturing related issues.The probable cause of the guide wire damage cannot be determined based on the information provided and without the guide wire being returned for evaluation.Teleflex will continue to monitor and trend for reports of this nature.
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