MalfunctionMPB
ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 20 CM
Received Jun 8, 2026 · Event occurred May 11, 2026
Report 3006425876-2026-00591 · MDR key 25426402
Device
Generic name
Catheter Hemodialytsis Non Imp
Manufacturer
Arrow International LlcCatalog number
CS-25122-F
Product problems
- Material Twisted/Bent
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
(B)(4).
Description of Event or Problem
IT WAS REPORTED THAT "THE SPRING WIRE GUIDE (SWG) TIP WAS BENT." THERE WERE NO REPORTS OF PATIENT INJURY, HARM, OR ADVERSE HEALTH CONSEQUENCES ASSOCIATED WITH THIS EVENT. THE PATIENT'S CONDITION WAS REPORTED AS "FINE". NO ADDITIONAL MEDICAL INTERVENTION WAS REPORTED BEYOND REMOVAL OF THE AFFECTED DEVICE, AND REPLACEMENT WITH ANOTHER DEVICE.