(b)(4).The customer returned one 3-lumen catheter for evaluation.The catheter body was cut; the separated portion was not returned.The catheter was returned with a saline-filled syringe attached to the medial luer hub.Visual examination of the returned catheter revealed one small cut on the medial extension line adjacent to the juncture hub.Microscopic examination revealed the cut was smooth in appearance.The extension line also contained adhesive residue.The appearance of the cut was consistent with contact with a sharp instrument (i.E.Scissors, scalpel, etc).The medial extension line was cut 18 mm from the juncture hub.The returned catheter body measured to be 85 mm, indicating that at least 73.5 mm were separated and not returned per product drawing.With the distal end of the catheter body occluded, water was injected into the all three extension lines using a lab inventory 10ml syringe.When water was injected into the medial extension line, water exited the cut.Functional testing of the distal and proximal extension lines did not reveal any leaks.A manual tug test confirmed the luer hubs were secure on the extension lines.A device history record review was performed with no relevant findings.The instructions-for-use provided with this kit cautions the user, "to minimize the risk of cutting catheter, do not use scissors to remove dressing." the customer report of the extension line leaking in use was confirmed through visual/functional inspection of the returned sample.Functional leak testing of the extension line revealed a small cut in the extension line.The edges of the cut were smooth and the appearance was consistent with contact with a sharp instrument (i.E.Scissors, scalpel, etc).A device history record review did not reveal any manufacturing related issues.Based on the condition of the returned sample, it was determined that operational context caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.
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