MalfunctionMPB
ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 20 CM
Received Jul 20, 2026 · Event occurred Jun 21, 2026
Report 3006425876-2026-00766 · MDR key 25883887
Device
Generic name
Catheter Hemodialytsis Non Imp
Manufacturer
Arrow International LlcCatalog number
CS-25122-F
Lot number
71F25H0564
Product problems
- Material Separation
- Unraveled Material
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT ON (b)(6) 2026, DURING INITIAL INSERTION OF AN ACUTE HEMODIALYSIS CATHETER (AHDC), THE SPRING WIRE GUIDE (SWG) WAS OBSERVED TO HAVE UNRAVELED AND THEN SEPARATED. THERE WERE NO REPORTS OF PATIENT INJURY, HARM, OR ADVERSE HEALTH CONSEQUENCES ASSOCIATED WITH THIS EVENT. THE PATIENT'S CONDITION WAS REPORTED AS "FINE." THE AFFECTED DEVICE WAS REMOVED AND REPLACED WITH ANOTHER DEVICE. NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED.
Additional Manufacturer Narrative
(b)(4).