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

Additional Manufacturer Narrative

(B)(4).

Description of Event or Problem

IT WAS REPORTED THAT: "ON (B)(6) 2024, PRIOR TO CATHETERIZATION, TEACHER FROM THE EMERGENCY DEPARTMENT IDENTIFIED THE SWG KINKED. NO PATIENT INVOLVED."

Description of Event or Problem

IT WAS REPORTED THAT: "(B)(6) 2024, PRIOR TO CATHETERIZATION, TEACHER FROM THE EMERGENCY DEPARTMENT IDENTIFIED THE SWG KINKED. NO PATIENT INVOLVED.".

Additional Manufacturer Narrative

(B)(4). THE REPORT OF A DAMAGED GUIDEWIRE WAS CONFIRMED THROUGH COMPLAINT INVESTIGATION OF THE RETURNED SAMPLE. THE CUSTOMER RETURNED ONE OPENED HEMODIALYSIS SET INCLUDING A GUIDEWIRE INSIDE THE ADVANCER ASSEMBLY, ARROW RAULERSON SYRINGE, TRANSDUCTION PROBE, 2-LUMEN CATHETER, SCALPEL, DILATOR, CATHETER-OVER-NEEDLE, AND INTRODUCER NEEDLE FOR ANALYSIS. NO SIGNS OF USE WERE OBSERVED. VISUAL ANALYSIS REVEALED OFFSET COILS ON THE J-BEND OF THE GUIDEWIRE. THE GUIDEWIRE MET ALL RELEVANT DIMENSIONAL AND FUNCTIONAL REQUIREMENTS. A DEVICE HISTORY RECORD REVIEW DID NOT REVEAL ANY RELEVANT FINDINGS. BECAUSE THE DAMAGE WAS OBSERVED IN AREAS WHERE THE PRODUCT WOULD HAVE BEEN PROTECTED IN THE PACKAGING, THE TIME OF THE DAMAGE CANNOT BE CONFIRMED. DUE TO THESE CIRCUMSTANCES, THE ROOT CAUSE OF THIS EVENT CANNOT BE DETERMINED AT THIS TIME. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR COMPLAINTS OF THIS NATURE.