FDA Adverse Event
Malfunction
Summary report: N
ARROW RA CATH SET: 20 GA X 1-3/4IN
MDR report key: 24910612
·
Received April 17, 2026
Report
- Report Number
- 9680794-2026-00313
- Event Type
- Malfunction
- Date Received
- April 17, 2026
- Date of Event
- March 31, 2026
- Report Date
- March 31, 2026
- Manufacturer
- ARROW INTERNATIONAL LLC
- Product Code
- OFB
- UDI-DI
- 00801902002730
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
(B)(4).
Description of Event or Problem · 0
IT WAS REPORTED THAT "WE HAD A RADIAL ARTERY CATHETERIZATION SET RA-04020 WHERE THE WIRE BROKE IN HALF WHEN INSERTING THE CATHETER INTO THE RADIAL ARTERY". THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 459692 | ARROW RA CATH SET: 20 GA X 1-3/4IN | WIRE GUIDE CATHETER | OFB | ARROW INTERNATIONAL LLC | 14F25K0378 | 00801902002730 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | NOT REPORTED. |