(b)(4).The customer returned one, opened, acute hemodialysis kit for analysis.The guide wire assembly will be analyzed as part of this complaint investigation.No definite signs of use were observed.Visual analysis did not reveal any defects or anomalies on the returned guide wire.Bending was noted on the outer tray; however, it is unknown if this occurred before or after the customer opened.The bending did not appear to affect the kit contents.The guide wire length measured 684mm, which is within the specification limits of 678mm-688mm per the guide wire product drawings.The guide wire outer diameter measured 0.840mm, which is within the specification limits of 0.838mm-0.877mm per the guide wire product drawings.A manual tug test confirmed that the distal and proximal welds were secure and intact.A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit informs 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 report of a kinked guide wire was not able to be confirmed through complaint investigation.The returned guide wire met all relevant visual and dimensional requirements, and a device history record review did not reveal any 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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