(b)(4).The customer returned multiple components from a cvc kit.The guide wire sub-assembly and a 2-lumen catheter will be analyzed for this complaint investigation.Visual examination revealed a slight kink in the guide wire near the distal tip.As a result, the j-tip of the guide wire was slightly deformed and did not have a consistent arc.Microscopic examination confirmed the kink and revealed signs-of-use in the form of biological material between the coils of the guide wire.The distal and proximal welds appeared spherical and intact.No other defects or anomalies were observed.The kink in the guide wire was 27mm from the distal tip.The length and outer diameter of the guide wire were measured and were found to be within specification.The catheter body from the juncture hub to the tip, and the catheter diameter were also within specification.The proximal end of the returned guide wire was passed through the distal tip of the catheter.Minor resistance was encountered when the kink in the guide wire reached the catheter; however, the guide wire was able the pass completely through.A manual tug test was performed on the guide wire.Both welds appeared to be secure in the assembly.A device history record review was performed with no relevant findings to suggest a manufacturing issue.The ifu provided with the kit states, "do not apply excessive force in removing guide wire or catheter.If withdrawal cannot be easily accomplished, a chest x-ray should be obtained, and further consultation requested." the ifu also warns the user, "do not withdraw spring-wire guide against needle bevel to minimize the risk of possible severing or damaging of spring-wire guide." the customer complaint of the "swg/catheter resistance - kinked" was confirmed through complaint investigation of the sample.The guide wire was examined, and a kink was found adjacent to the j-tip.Traces of biological material were also observed.Functional testing proved that the returned guide wire could pass completely through the catheter body with minor resistance.The guide wire and catheter met all relevant dimensional requirements, and a device history record review did not reveal any relevant findings.Based on the customer description and the returned sample, it was determined that unintentional user error likely caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.
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