FDA Adverse Event
Malfunction
Summary report: N
72" 20 DEOP PRIMAY SET ROTATING LUER
MDR report key: 1843467
·
Received August 31, 2010
Report
- Report Number
- 1843467
- Event Type
- Malfunction
- Date Received
- August 31, 2010
- Date of Event
- August 24, 2010
- Report Date
- August 31, 2010
- Manufacturer
- ICU MEDICAL
- Product Code
- FPA
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- AZ, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
TUBING WOULD NOT ALLOW FLUIDS TO RUN. NEW TUBING WAS USED AND WORKED OK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 72" 20 DEOP PRIMAY SET ROTATING LUER | INFUSION SET | FPA | ICU MEDICAL | SF3040-20 | 1967971 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |