Qn# (b)(4).The customer report of a catheter leak was confirmed through complaint investigation of the returned sample.The customer returned one hemodialysis catheter connector for analysis.The threaded compression sleeve, the catheter body, and the compression sleeve were not returned for analysis.After failing functional testing, a leak was observed where the metal prongs meet the juncture hub of the connector assembly.A leak test was performed on the connector assembly.With the distal ends of the metal prongs occluded, water was injected using a lab inventory 10ml syringe through each of the extension lines.When injecting water through the lumen with the red clamp, a leak was observed at the connection point between the metal prongs and the juncture hub.No leaks were observed when injecting water through the lumen with the blue extension line.The instructions-for-use (ifu) provided with the kit informs the user "ensure compression sleeve is securely positioned inside threaded compression cap.Avoid attempts to place compression sleeve onto hub connection assembly cannula and then apply threaded compression cap.Incomplete compression may occur causing catheter separation." a device history record review was performed with no relevant findings.Based on the condition of the returned device and the customer description, manufacturing caused or contributed to this event.Investigation has been initiated under teleflex's quality system by the manufacturing site to further investigate this issue.Teleflex will continue to monitor and trend for reports of this nature.
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