FDA Adverse Event
Injury
Summary report: N
LIFEPORT VASCULAR ACCESS SYSTEM
MDR report key: 512901
·
Received February 25, 2004
Report
- Report Number
- 1056436-2004-00006
- Event Type
- Injury
- Date Received
- February 25, 2004
- Date of Event
- January 30, 2004
- Report Date
- February 25, 2004
- Manufacturer
- HORIZON MEDICAL PRODUCTS, INC.
- Product Code
- LJT
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IN 02/2004, THE USER FACILITIES RADIOLOGY DEPARTMENT INFORMED THE MANUFACTURER'S REPRESENTATIVE OF THE FOLLOWING: THE NIGHT IV NURSE CALLED TO EVALUATE PORT. PORT LEAKING PINK TINITED FLUID DURING TPN IV. PORT ACCESSED POSITIVE BLOOD RETURN, CONTINUED LEAKING. EXPLANTED PORT, IMPLANTED EXTERNAL CENTRAL VENOUS CATHETER ON OPPOSITE SIDE. A LITTLE REDNESS OBSERVED AT PORT SITE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIFEPORT VASCULAR ACCESS SYSTEM | VASCULAR ACCESS PORT | LJT | HORIZON MEDICAL PRODUCTS, INC. | NA | 18578 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |