FDA Adverse Event
Malfunction
Summary report: N
MERIDIAN FILTER SYSTEM - JUGULAR
MDR report key: 2904601
·
Received December 5, 2012
Report
- Report Number
- 2020394-2012-00275
- Event Type
- Malfunction
- Date Received
- December 5, 2012
- Date of Event
- November 13, 2012
- Report Date
- November 16, 2012
- Manufacturer
- BARD PERIPHERAL VASCULAR, INC.
- Product Code
- DTK
- PMA / PMN Number
- K102511
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE LOT NUMBER WAS NOT PROVIDED; THEREFORE, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. THE INVESTIGATION IS CURRENTLY UNDERWAY.
Description of Event or Problem · 1
IT WAS REPORTED THAT UPON DEPLOYMENT OF A VENA CAVA FILTER THE ARMS AND LEGS WERE CROSSED AND A CATHETER WAS PLACED OVER THE GUIDE WIRE TO ACCESS THE FILTER AND UNCROSS THE LIMBS. THE FILTERS LIMBS WERE SUCCESSFULLY UNCROSSED AND THE FILTER REMAINS IMPLANTED. NO REPORTED PATIENT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MERIDIAN FILTER SYSTEM - JUGULAR | DTK | BARD PERIPHERAL VASCULAR, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |