FDA Adverse Event
Malfunction
Summary report: N
DISPOSABLE NORMOTHERMIC IV ADMINISTRATION SET
MDR report key: 1010487
·
Received February 7, 2008
Report
- Report Number
- 1010487
- Event Type
- Malfunction
- Date Received
- February 7, 2008
- Date of Event
- January 21, 2008
- Report Date
- February 7, 2008
- Manufacturer
- SMITHS MEDICAL ASD, INC.
- Product Code
- FPA
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- IL, US
Narratives
Description of Event or Problem · 1
TUBING STARTED TO LEAK, AND NEW TUBING WAS OPENED AND USED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DISPOSABLE NORMOTHERMIC IV ADMINISTRATION SET | TUBING, IV, FLUID WARMING | FPA | SMITHS MEDICAL ASD, INC. | D-50 | 1224505 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 43 YR |