FDA Adverse Event
Injury
Summary report: N
CARDINAL HEALTH
MDR report key: 655219
·
Received December 22, 2005
Report
- Report Number
- 655219
- Event Type
- Injury
- Date Received
- December 22, 2005
- Date of Event
- November 1, 2005
- Report Date
- November 10, 2005
- Manufacturer
- CARDINAL HEALTH
- Product Code
- KDQ
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
DURING A THORACENTESIS, THE INNER WHITE CANNULA BEGAN TO BREAK APART. THE CANNULA WAS WITHDRAWN AND A NEW SET WAS USED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CARDINAL HEALTH | THORACENTESIS TRAY WITH CATHETER | KDQ | CARDINAL HEALTH | * | L4L161 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Required Intervention |