FDA Adverse Event
Injury
Summary report: N
LIFEPORT VASCULAR ACCESS SYSTEM
MDR report key: 517502
·
Received March 24, 2004
Report
- Report Number
- 1056436-2004-00014
- Event Type
- Injury
- Date Received
- March 24, 2004
- Date of Event
- February 25, 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
- OH, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
IN 03/2004 THE USER FACILITY'S QA ANALYST INFORMED THE MFR'S REP OF THE FOLLOWING: THIS PATIENT WITH A HISTORY OF ESOPHAGEAL CANCER, HAD A PORT PLACED IN 2004. RECENTLY, PATIENT NOTICED SIGNS OF INFECTIONS AT THE SITE OF THE PORT AND POSSIBLY LEAKAGE AS WELL. PATIENT'S DOCTOR ORDERED AN ANGIOGRAM IN 02/2004, WHICH REVEALED A LEAK OF CONTRAST NEAR THE CONNECTION SITE. THE PATIENT THEN HAD THE PORT REMOVED AND REPLACED WITH A NEW ONE THAT DAY. PATIENT TOLERATED THE PROCEDURE WELL AND WAS DISCHARGED HOME SAME DAY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIFEPORT VASCULAR ACCESS SYSTEM | VASCULAR ACCESSPORT | LJT | HORIZON MEDICAL PRODUCTS, INC. | LPS7523 | 19261 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 44 YR |