(b)(4).The customer returned one 3-lumen cvc for evaluation.The sample contained obvious signs of use in the form of biological material.Visual examination did not reveal any defects or anomalies.The length of the returned catheter body measured to be 168 mm which is within specifications of 157-177 mm per product drawing.All three extension lines were initially flushed using a lab inventory syringe.Slight resistance was encountered while flushing the medial line.Once the biological material was cleared from the line, all lumens functioned as expected.A device history record review was performed with no relevant findings.The ifu provided with this kit cautions the user, "indwelling catheters should be routinely inspected for desired flow rate, security of dressing, correct catheter position and for secure luer-lock connection.Use centimeter markings to identify if the catheter position has changed." the customer report of a blocked extension line could not be confirmed by complaint investigation of the returned sample.After the biological material was flushed from each line, all lumens functioned as expected.A device history record review was performed with no relevant findings.No problem was found with the returned sample.Teleflex will continue to monitor and trend for complaints of this nature.
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