FDA Adverse Event
Injury
Summary report: N
LIFEPORT VASCULAR ACCESS SYSTEM
MDR report key: 517369
·
Received March 24, 2004
Report
- Report Number
- 1056436-2004-00013
- Event Type
- Injury
- Date Received
- March 24, 2004
- Date of Event
- February 24, 2004
- Report Date
- March 24, 2004
- Manufacturer
- HORIZON MEDICAL PRODUCTS, INC.
- Product Code
- LJT
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
THE PORT WAS STATED TO BE LEAKING DURING DYE STUDY. THE PORT WAS FLUSHED ONCE, REMOVED BY THE PHYSICIAN AND OBSERVED NOT BE LEAKING. THERE MAY HAVE BEEN FIBRIN SHEATH PRESENT, THE DEVICE WAS DISCARDED AND NOT AVAILABLE TO BE RETURNED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIFEPORT VASCULAR ACCESS SYSTEM | VASCULAR ACCESS PORT | LJT | HORIZON MEDICAL PRODUCTS, INC. | LPS5200 | 19260 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |