FDA Adverse Event
Injury
Summary report: N
HORIZON MEDICAL PRODUCTS, INC.
MDR report key: 408192
·
Received August 1, 2002
Report
- Report Number
- 408192
- Event Type
- Injury
- Date Received
- August 1, 2002
- Date of Event
- July 5, 2002
- Report Date
- July 8, 2002
- Manufacturer
- HORIZON MEDICAL PRODUCTS, INC.
- Product Code
- LJT
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
PT CAME TO HOSPITAL BECAUSE VASCULAR PORT NOT WORKING. FLUOROSCOPY SHOWED CATHETER BROKEN AT THE LEVEL OF THE CLAVICLE. PIECE OF CATHETER IN RIGHT VENTRICLE. PORT AND SEGMENT REMOVED FROM PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HORIZON MEDICAL PRODUCTS, INC. | TRIUMPH 1 VASCULAR ACCESS SYSTEM | LJT | HORIZON MEDICAL PRODUCTS, INC. | * | 1-523051A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR | Required Intervention |