FDA Adverse Event
Malfunction
Summary report: N
MERIDIAN FILTER SYSTEM - JUGULAR
MDR report key: 3043427
·
Received March 11, 2013
Report
- Report Number
- 2020394-2013-00064
- Event Type
- Malfunction
- Date Received
- March 11, 2013
- Date of Event
- February 15, 2013
- Report Date
- February 20, 2013
- Manufacturer
- BARD PERIPHERAL VASCULAR, INC.
- Product Code
- DTK
- PMA / PMN Number
- K102511
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE LOT NUMBER HAS BEEN PROVIDED AND THE DEVICE HISTORY RECORDS ARE BEING REVIEWED. THE INVESTIGATION IS CURRENTLY UNDERWAY.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A SCHEDULED VENA CAVA FILTER RETRIEVAL, TWO DETACHED FILTER LIMBS WERE NOTED TO BE EMBEDDED IN THE IVC WALL. THE FILTER WAS REMOVED; HOWEVER, ATTEMPTS TO REMOVE THE DETACHED LIMBS WERE UNSUCCESSFUL. THERE WAS NO REPORTED PATIENT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 102878 | MERIDIAN FILTER SYSTEM - JUGULAR | DTK | BARD PERIPHERAL VASCULAR, INC. | GFWD0789 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |