(b)(4).The customer returned one 3-lumen cvc for evaluation.Visual examination of the returned sample did not reveal any defects or anomalies.No kinks or damage was observed.The total length of the catheter body measured to be 320 mm which is within specifications of 310-330 mm per product drawing.All three lumens were flushed using a lab inventory syringe.The distal lumen flushed with minimal resistance.When the proximal and medial lumens were flushed, resistance was encountered.Significant biological material was cleared from the lines, then the catheter flushed as expected.A lab inventory guide wire was able to pass through the returned catheter with minimal resistance.A device history record review was performed with no relevant findings.The ifu provided with this kit cautions the user, "ensure catheter patency prior to use.Do not use syringes smaller than 10 ml (a fluid filled 1 ml syringe can exceed 300 psi) to reduce risk of intraluminal leakage or catheter rupture." the customer report of a blocked catheter was confirmed by complaint investigation of the returned sample.The catheter contained a significant amount of biological material build up in the catheter.A device history record review was performed with no relevant findings.Based on the condition of the sample received, unintentional user error caused or contributed to this event.Teleflex will continue to monitor and trend for complaints of this nature.
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