ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 16 CM

Description of Event or Problem

IT WAS REPORTED THAT: "(B)(4) 2024, BEFORE INSERTION, HEALTH PROFESSIONAL IN EMERGENCY DEPARTMENT FOUND THAT THE GUIDEWIRE WAS KINKED."

Additional Manufacturer Narrative

QN# (B)(4). THE REPORT THAT THE GUIDEWIRE WAS KINKED WAS CONFIRMED THROUGH THE COMPLAINT INVESTIGATION OF THE RETURNED SAMPLE. THE CUSTOMER RETURNED ONE OPENED HEMODIALYSIS KIT, INCLUDING ONE GUIDEWIRE WITHIN ITS ADVANCER, AN ARROW RAULERSON SYRINGE (ARS), CATHETER, NEEDLES, AND DUST CAP FOR ANALYSIS. ONE KINK WAS OBSERVED TOWARDS THE DISTAL END OF THE GUIDEWIRE BODY. THE DISTAL J-BEND WAS MISSHAPEN. MICROSCOPIC EXAMINATION CONFIRMED THE KINK IN THE GUIDEWIRE BODY. THE GUIDEWIRE MET ALL RELEVANT DIMENSIONAL AND FUNCTIONAL REQUIREMENTS, AND A DEVICE HISTORY RECORD REVIEW WAS PERFORMED WITH NO RELEVANT FINDINGS. DURING NORMAL ASSEMBLY, THE KINKED PORTION OF THE GUIDEWIRE WOULD BE PROTECTED WITHIN THE STRAIGHTENING TUBE OF THE ADVANCER ASSEMBLY. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED, AND NO RELEVANT FINDINGS WERE IDENTIFIED. BASED ON THE CUSTOMER REPORT AND SAMPLE RECEIVED, THE POTENTIAL ROOT CAUSE CANNOT BE DETERMINED, AS IT CANNOT BE CONFIRMED WHEN THE DAMAGE OCCURRED. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR COMPLAINTS OF THIS NATURE.

Additional Manufacturer Narrative

(B)(4).

Description of Event or Problem

IT WAS REPORTED THAT: "(B)(6) 2024, BEFORE INSERTION, HEALTH PROFESSIONAL IN EMERGENCY DEPARTMENT FOUND THAT THE GUIDEWIRE WAS KINKED."