ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 13 CM
Received Apr 14, 2026 · Event occurred Mar 14, 2026
Report 3006425876-2026-00391 · MDR key 24869476
Device
Generic name
Catehter Hemodialysis Non Impl
Manufacturer
Arrow International LlcCatalog number
CU-23122-F
Lot number
71F25A0687
Product problems
- Material Twisted/Bent
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
(B)(4) THE REPORT THAT THE GUIDEWIRE KINKED DURING USE WAS CONFIRMED THROUGH EXAMINATION OF THE RETURNED SAMPLE AND CUSTOMER SUPPLIED PHOTO. THE GUIDEWIRE WAS KINKED AT 3 LOCATIONS THROUGHOUT THE GUIDEWIRE BODY. THE RETURNED GUIDEWIRE MET ALL RELEVANT DIMENSIONAL AND FUNCTIONAL REQUIREMENTS, AND A DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY MANUFACTURING RELATED ISSUES. BASED ON THE CONDITION OF THE GUIDEWIRE AND THE REPORT THAT THE DAMAGE WAS OBSERVED DURING USE, UNINTENTIONAL USE ERROR CAUSED OR CONTRIBUTED TO THIS EVENT. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.
Description of Event or Problem
IT WAS REPORTED THAT: "ON (B)(6) 2026, DURING CATHETERIZATION IN THE KIDNEY TRANSPLANT DEPARTMENT, IT WAS FOUND THAT THE GUIDE WIRE HAD MULTIPLE KINKS AND COULD NOT BE USED NORMALLY. AFTER REPLACING IT, IT WAS SUCCESSFULLY INSERTED."