MalfunctionOFB
ARROW RA CATH SET: 22 GA X 1-3/8IN
Received Jun 15, 2026 · Event occurred May 19, 2026
Report 9680794-2026-00459 · MDR key 25512461
Device
Generic name
Wire Guide Catheter
Manufacturer
Arrow International LlcCatalog number
RA-04122
Lot number
14F25G0096
Product problems
- Device Damaged Prior to Use
- Material Twisted/Bent
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED ON (B)(6) 2026, DURING PRODUCT PREPARATION FOR AN ARTERIAL CATHETER INSERTION, THE SPRING WIRE GUIDE (SWG)/TUBE ASSEMBLY WERE OBSERVED TO BE KINKED IN A C-SHAPE UPON OPENING THE PACKAGE. THE EVENT OCCURRED PRIOR TO USE ON THE PATIENT, AND THE DEVICE WAS NOT USED. THERE WAS NO PATIENT INVOLVEMENT. NO PATIENT INJURY, HARM, OR ADVERSE HEALTH CONSEQUENCES WERE REPORTED IN ASSOCIATION WITH THIS EVENT.
Additional Manufacturer Narrative
(B)(4)