ARROW HEMODIALYSIS KIT: 2L 14 FR X 15 CM AGB
Received Jul 24, 2025 · Event occurred Jun 30, 2025
Report 9680794-2025-00625 · MDR key 22588362
Device
Generic name
Catheter, Hemodialysis, Non-i
Manufacturer
Arrow International LlcCatalog number
CDC-22142-X1A
Lot number
33F24L0278
Product problems
- Unraveled Material
- Material Split, Cut or Torn
- Unraveled Material
- Material Split, Cut or Torn
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
(B)(4).
Description of Event or Problem
IT WAS REPORTED "DR. WAS PLACING A TEMPORARY DIALYSIS CATHETER AND WHEN HE ATTEMPTED TO REMOVE THE GUIDEWIRE, IT BEGAN SPLITTING/UNCOILING REQUIRING HIM TO REMOVE THE ENTIRE CATHETER. DESPITE THE GUIDEWIRE SPLITTING, DR. WAS ABLE TO REMOVE THE ENTIRE GUIDEWIRE." THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".
Additional Manufacturer Narrative
QN#(B)(4). COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED AS IT WAS REPORTED THAT THE SAMPLE IS NOT AVAILABLE FOR RETURN. 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.
Description of Event or Problem
IT WAS REPORTED "DR. WAS PLACING A TEMPORARY DIALYSIS CATHETER AND WHEN HE ATTEMPTED TO REMOVE THE GUIDEWIRE, IT BEGAN SPLITTING/UNCOILING REQUIRING HIM TO REMOVE THE ENTIRE CATHETER. DESPITE THE GUIDEWIRE SPLITTING, DR. WAS ABLE TO REMOVE THE ENTIRE GUIDEWIRE." THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".