(b)(4).The customer returned one opened kit containing a 3-lumen cvc for evaluation.The catheter contained obvious signs of use in the form of biological material.Visual examination did not reveal any defects or anomalies.The total length of the returned catheter measured to be 217 mm which is within specifications of 207-227 mm per product drawing.All three lumens were flushed using a water-filled lab inventory syringe.When the medial and proximal lines were flushed, significant resistance was encountered.Biological material was removed from the lines and all three lumens were able to flush as intended.A device history record review was performed with no relevant findings.The ifu provided with this kit instructs the user to prepare the catheter, "flush each lumen with sterile normal saline for injection to establish patency and prime lumen(s).".The customer report of two blocked lumens was confirmed by functional testing of the returned sample.However, once biological material was removed from the lines, all three lumens functioned as intended.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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