MalfunctionMPB
ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 13 CM
Received Jun 9, 2026 · Event occurred May 8, 2026
Report 3006425876-2026-00618 · MDR key 25446687
Device
Generic name
Catehter Hemodialysis Non Impl
Manufacturer
Arrow International LlcCatalog number
CU-23122-F
Lot number
71F25A0687
Product problems
- Device Damaged Prior to Use
- 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 ON (B)(6) 2026, THE OPERATING PHYSICIAN OBSERVED THAT THE SPRING WIRE GUIDE (SWG) WAS KINKED PRIOR TO THE INSERTION PROCEDURE. THE SWG WAS REPLACED WITH A NEW DEVICE, WHICH RESOLVED THE ISSUE AND ALLOWED THE PROCEDURE TO PROCEED AS PLANNED. THERE WAS NO PATIENT INVOLVEMENT, AND NO ADVERSE PATIENT IMPACT OR INJURY WAS REPORTED IN ASSOCIATION WITH THIS EVENT.