ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 20 CM
Received Nov 19, 2025 · Event occurred Oct 28, 2025
Report 3006425876-2025-01070 · MDR key 23593932
Device
Generic name
Catheter Hemodialytsis Non Imp
Manufacturer
Arrow International LlcCatalog number
CS-25122-F
Lot number
71F24B1199
Product problems
- Material Twisted/Bent
- Material Twisted/Bent
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT "THE GUIDE WIRE KINKING. THERE WAS NO REPORTED PATIENT HARM OR CONSEQUENCE."
Additional Manufacturer Narrative
(B)(4).
Description of Event or Problem
IT WAS REPORTED THAT "THE GUIDE WIRE KINKING. THERE WAS NO REPORTED PATIENT HARM OR CONSEQUENCE.".
Additional Manufacturer Narrative
(B)(4). COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED AS NO SAMPLE WAS RETURNED FOR ANALYSIS. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED, AND NO RELEVANT FINDINGS WERE IDENTIFIED. WITHOUT THE DEVICE TO EVALUATE, THE COMPLAINT COULD NOT BE CONFIRMED, AND THE PROBABLE CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.