(b)(4).The customer returned an opened set with various components for investigation.The returned catheter had signs of use in the form of biological material on the interior and exterior of the catheter body and extension lines.No other anomalies were found.The proximal extension line of the returned catheter was attached to a lab syringe full of water.The plunger was depressed and the water exited the proximal skive.The distal extension line of the returned catheter was then attached to a lab syringe full of water.The plunger was depressed and resistance was met.A wire was then passed through the distal line and catheter body and dried blood exited the distal end.The plunger was again depressed and water exited accordingly.A device history record (dhr) review was performed with no relevant findings.The instructions for use (ifu) provided with this kit instructs the user to "prepare the catheter for insertion by flushing each lumen and clamping or attaching the injection caps to the appropriate extension line(s).Leave the distal extension line uncapped for guide wire passage." the customer complaint of a catheter blockage was confirmed by complaint investigation.When a lab syringe full of water was connected to the distal extension line, resistance was met when flushing the line.However, a wire was used to unclog the catheter.Significant amounts of coagulated blood were found in the catheter body.Once the blood was removed, the line was able to flush normally.Based on the sample as received, it was determined that operational context caused or contributed to this event.
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