FDA Adverse Event
Malfunction
Summary report: N
ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 20 CM
MDR report key: 24923912
·
Received April 20, 2026
Report
- Report Number
- 3006425876-2026-00428
- Event Type
- Malfunction
- Date Received
- April 20, 2026
- Date of Event
- January 29, 2026
- Report Date
- March 26, 2026
- Manufacturer
- ARROW INTERNATIONAL LLC
- Product Code
- PPO
- UDI-DI
- 10801902190366
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
(B)(4).
Description of Event or Problem · 0
IT WAS REPORTED THAT: "(B)(6) 2026, DURING THE PATIENT'S HEMODIALYSIS CATHETERIZATION PROCESS, THE DELIVERY OF THE GUIDEWIRE WENT SMOOTHLY. HOWEVER, AFTER THE SKIN EXPANSION AND INCISION, THE CATHETER WAS DIFFICULT TO ADVANCED ONTO THE SWG AND IT WAS FOUND THAT THE GUIDEWIRE WAS KINKED, IT DID NOT CAUSE ANY HARM TO THE PATIENT. THE DEVICE WAS REPLACED TO RESOLVE THE ISSUE."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 253073 | ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 20 CM | CATHETER SUBCLAVIAN | PPO | ARROW INTERNATIONAL LLC | 71F24L0891 | 10801902190366 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | NOT REPORTED |