FDA Adverse Event
Malfunction
Summary report: N
IMPLANTED PORT WITH GROSHONG CATHETER
MDR report key: 1061159
·
Received June 2, 2008
Report
- Report Number
- 1061159
- Event Type
- Malfunction
- Date Received
- June 2, 2008
- Date of Event
- April 11, 2008
- Report Date
- June 2, 2008
- Manufacturer
- BARD ACCESS SYSTEMS
- Product Code
- LJT
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- FL, US
Narratives
Description of Event or Problem · 1
PORT IMPLANTED RECENTLY. IT WAS REMOVED NINE DAYS LATER. CATHETER FRACTURED AT JUNCTION/CONNECTION WITH DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | IMPLANTED PORT WITH GROSHONG CATHETER | PORT,VASCULAR ACCESS | LJT | BARD ACCESS SYSTEMS | * | RERK0667 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 43 YR |