FDA Adverse Event
Malfunction
Summary report: N
CAREFUSION
MDR report key: 2941313
·
Received January 25, 2013
Report
- Report Number
- MW5028792
- Event Type
- Malfunction
- Date Received
- January 25, 2013
- Date of Event
- January 20, 2013
- Report Date
- January 25, 2013
- Manufacturer
- CAREFUSION
- Product Code
- FPA
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
SECONDARY I.V. FLUID NOTICEABLY BY PASSED THE IN-LINE CHECK VALVE AND ENTERED THE DRIP CHAMBER AS WELL AS THE PRIMARY I.V. FLUID BAG.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 36260 | CAREFUSION | INFUSION SET | FPA | CAREFUSION | 2420-0500 | 12115251 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |