FDA Adverse Event
Injury
Summary report: N
LIFEPORT VASCULAR ACCESS SYSTEM
MDR report key: 296790
·
Received September 20, 2000
Report
- Report Number
- 1056436-2000-00187
- Event Type
- Injury
- Date Received
- September 20, 2000
- Date of Event
- August 17, 2000
- Report Date
- August 22, 2000
- Manufacturer
- HORIZON MEDICAL PRODUCTS, INC.
- Product Code
- LJT
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
ON 8/22/2000, THE FACILITY'S SPECIALTY COORDINATOR, SURGERY INFORMED THE MFR'S SALES REP OF THE FOLLOWING: THE DEVICE CATHETER FRACTURED, APPARENT "PINCH-OFF." NO FURTHER DETAILS WERE PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIFEPORT VASCULAR ACCESS SYSTEM | VASCULAR ACCESS DEVICE | LJT | HORIZON MEDICAL PRODUCTS, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 44 YR | Required Intervention |