(b)(4).The customer returned one unopened representative kit from the reported lot.The actual complaint sample was not returned for evaluation.The kit was opened, and the catheter was visually inspected.No defects or anomalies were detected.Visual inspection of the actual sample could not be performed as it was not returned for evaluation.The total length of the representative catheter body measured to be 6.9" which is within specifications of 6.6875-6.9375" per product drawing.The returned representative sample was functionally tested in accordance with the instructions-for-use (ifu) provided with this kit.The ifu instructs the user, "flush each lumen with sterile normal saline for injection to establish patency and prime lumen(s)." the representative catheter was flushed using a water-filled lab inventory syringe with minimal resistance.The representative catheter was able to advance over the representative guide wire with minimal resistance.A device history record review was performed with no relevant findings.The ifu provided with this kit instructs the user, "flush each lumen with sterile normal saline for injection to ebstablish patency and prime lumen(s)." the customer report of a blocked catheter could not be confirmed by complaint investigation.The returned representative catheter passed all relevant visual, dimensional, and functional tests.A device history record review was performed with no relevant findings.The probable root cause could not be determined based on the information provided and without the actual complaint sample to evaluate.Teleflex will continue to monitor and trend reports of this nature.
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