ARROW HEMODIALYSIS KIT 2L: 14 FR X 15CM AGB
Received Aug 15, 2025 · Event occurred Jul 18, 2025
Report 9680794-2025-00693 · MDR key 22814434
Device
Generic name
Catheter Hemodialysis Implante
Manufacturer
Arrow International LlcCatalog number
AK-22142-CDC
Lot number
33F24F0134
Product problems
- Material Frayed
- Material Frayed
Patient
NA · Unknown
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
IT WAS REPORTED "THE WIRE FRAYED UPON INSERTION". A NEW KIT WAS OPENED AND THE LINE WAS PLACED SUCCESSFULLY. THERE WAS NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "STABLE".
Additional Manufacturer Narrative
QN# (B)(4).
Additional Manufacturer Narrative
(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 "THE WIRE FRAYED UPON INSERTION". A NEW KIT WAS OPENED AND THE LINE WAS PLACED SUCCESSFULLY. THERE WAS NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "STABLE".