FDA Adverse Event
Other
Summary report: N
LIFEPORT VASCULAR ACCESS SYSTEM
MDR report key: 250811
·
Received November 19, 1999
Report
- Report Number
- 1056436-1999-00196
- Event Type
- Other
- Date Received
- November 19, 1999
- Date of Event
- October 25, 1999
- Report Date
- October 25, 1999
- Manufacturer
- HORIZON MEDICAL PRODUCTS, INC.
- Product Code
- LJT
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
ON 10/25/1999, THE FACILITY'S MATERIALS MANAGER INFORMED THE MANUFACTURER'S (MFR.) REPRESENTATIVE OF THE FOLLOWING: WHEN THE DEVICE WAS OPENED FOR THE PROCEDURE, THE ANGLED RUBER NEEDLE AND INTRODUCER WERE NOTED MISSING. ANOTHER DEVICE WAS OBTAINED FOR THE PROCEDURE. 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 | 14765 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |