FDA Adverse Event
Malfunction
Summary report: N
SKATER¿ SAFETY CENTESIS CATHETER
MDR report key: 21066524
·
Received January 3, 2025
Report
- Report Number
- 21066524
- Event Type
- Malfunction
- Date Received
- January 3, 2025
- Date of Event
- December 11, 2024
- Report Date
- December 18, 2024
- Manufacturer
- ARGON MEDICAL DEVICES, INC.
- Product Code
- OJT
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- AZ
- Reporter Occupation
- RISK MANAGER
- Health Professional
- N
Narratives
Description of Event or Problem · 0
PRODUCT NEEDLE DOES NOT FIT INTO THE SLEEVE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 775225 | SKATER¿ SAFETY CENTESIS CATHETER | ASPIRATION TRAY | OJT | ARGON MEDICAL DEVICES, INC. | 700606016 | 11596269 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |