Qn# (b)(4).The customer returned one, opened picc kit for analysis.No definite signs of use were observed.It was noted that the catheter body was intentionally severed at the 40cm marking.The severed portion was not returned for analysis.The guide wire will be reviewed as part of this complaint investigation.Visual analysis of the guide wire and tubing did not reveal any kinking/bending of any kind.The guide wire length from the proximal end to the distal tip measured 45.2cm, which is within the specification limits of 43.75cm-46.25cm per the guide wire product drawing.The guide wire outer diameter measured.0179", which is within the specification limits of.0160"-.0180" per the guide wire product drawing.The returned guide wire was inserted through the returned introducer needle.Little to no resistance was encountered as the guide wire passed completely through the component.Performed per ifu statement, "insert soft tip of 33 cm or 45 cm guidewire through introducer needle into vein.Advance guidewire to desired depth".A manual tug test confirmed that the distal weld was secure and intact.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 withdraw guidewire against needle bevel to reduce the risk of possible severing or damaging of guidewire".The report of a kinked guide wire before use was not able to be confirmed through complaint investigation.Visual analysis did not reveal any defects or anomalies.Additionally, the guide wire met all relevant dimensional and functional requirements, and a device history record review was performed based on sales history with no relevant findings.Based on the customer report and the sample received, no problem was found with the returned device.Teleflex will continue to monitor and trend for reports of this nature.
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