FDA Adverse Event
Malfunction
Summary report: N
ON-Q
MDR report key: 1933921
·
Received December 10, 2010
Report
- Report Number
- 1933921
- Event Type
- Malfunction
- Date Received
- December 10, 2010
- Date of Event
- November 30, 2010
- Report Date
- December 10, 2010
- Manufacturer
- I-FLOW CORPORATION
- Product Code
- MEB
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- MI, US
Narratives
Description of Event or Problem · 1
PT HAS AN ON-Q PAIN PUMP. PUMP LEAKED SEVERELY THROUGH THE CONTROL DIAL TO THE POINT THAT THE LINENS ON THE BED HAD TO BE CHANGED. PUMP WAS CHANGED OUT. THIS WAS A 400ML PAIN PUMP, MODEL #CB004, LOT #082236.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ON-Q | PUMP, INFUSION, ELASTOMERIC | MEB | I-FLOW CORPORATION | CB004 | 082236 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |