FDA Adverse Event
Malfunction
Summary report: N
CORPAK
MDR report key: 2030814
·
Received March 22, 2011
Report
- Report Number
- MW5019924
- Event Type
- Malfunction
- Date Received
- March 22, 2011
- Date of Event
- March 22, 2011
- Report Date
- March 22, 2011
- Manufacturer
- CORAK
- Product Code
- FPD
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- PA, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
THE TUBING ON A POLAR FEED BAG WAS LEAKING. THE NURSE CARING FOR THE RESIDENT STATED THAT THE TUBE FEEDING WERE BUBBLING OUT OF THE TOP OF THE DRIP CHAMBER. THE RESIDENT WAS NOT HARMED. A NEW SET UP FOR THE FEEDINGS WAS OBTAINED AND PLACED FOR THE RESIDENT. THE TUBING WAS SENT TO PURCHASING FOR ANALYSIS AND A MEDWATCH REPORT WAS COMPLETED. DIAGNOSIS OR REASON FOR USE: GLIOBLASTOMA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CORPAK | POLAR ENTERAL BAG W/ ATTACHED PUMP | FPD | CORAK | 28-2013 SIZE 1200 | 42696 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR |