FDA Adverse Event
Malfunction
Summary report: N
SMARTSITE INFUSION SET
MDR report key: 1271520
·
Received December 17, 2008
Report
- Report Number
- 1271520
- Event Type
- Malfunction
- Date Received
- December 17, 2008
- Date of Event
- December 11, 2008
- Report Date
- December 17, 2008
- Manufacturer
- CARDINAL HEALTH MEDICAL PRODUCTS & SERVICES
- Product Code
- FPA
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- CA, US
Narratives
Description of Event or Problem · 1
MEDICATION FOUND DRIPPING ON THE FLOOR FROM IV TUBING. THE TUBING HAD A HOLE FOUND IN THE REGION RIGHT BELOW THE BLUE TOP PIECE THAT SITS IN THE ACTUAL PUMP. THE TUBING WAS REPLACED, THERE WAS NO PATIENT HARM.
Description of Event or Problem · 1
MEDICATION FOUND DRIPPING ON THE FLOOR FROM IV TUBING. THE TUBING HAD A HOLE FOUND IN THE REGION RIGHT BELOW THE BLUE TOP PIECE THAT SITS IN THE ACTUAL PUMP. THE TUBING WAS REPLACED, THERE WAS NO PATIENT HARM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SMARTSITE INFUSION SET | TUBING, IV | FPA | CARDINAL HEALTH MEDICAL PRODUCTS & SERVICES | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 18 YR |