MalfunctionOFB
ARROW RA CATH KIT: 20 GA X 12 CM
Received Apr 16, 2026 · Event occurred Mar 30, 2026
Report 9680794-2026-00354 · MDR key 24895610
Device
Generic name
Wire, Guide, Catheter
Manufacturer
Arrow International LlcCatalog number
NA-04550-1A
Lot number
33F25K0199
Product problems
- Material Twisted/Bent
Patient
NA · Unknown
- Insufficient Information
Narrative
Description of Event or Problem
IT WAS REPORTED "ON INSERTION WIRE KINKED SO SECOND KIT OPENED AND THE WIRE KINKED AS WELL UNABLE TO PLACE LINE". THERE WAS NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS UNKNOWN AT THIS TIME. ASSOCIATE MDR NUMBERS INCLUDE: 9680794-2026-00305.
Additional Manufacturer Narrative
(B)(4)