FDA Adverse Event
Malfunction
Summary report: N
RECOVERY FILTER SYSTEM
MDR report key: 2012124
·
Received February 14, 2011
Report
- Report Number
- 2020394-2011-00031
- Event Type
- Malfunction
- Date Received
- February 14, 2011
- Date of Event
- January 18, 2011
- Report Date
- January 20, 2011
- Manufacturer
- BARD PERIPHERAL VASCULAR, INC.
- Product Code
- DTK
- PMA / PMN Number
- K031328
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE LOT NUMBER FOR THE DEVICE IS UNK. THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE PERFORMED. THE DEVICE WAS DISCARDED BY THE USER FACILITY. THEREFORE, A SAMPLE EVAL COULD NOT BE PERFORMED. THE INVESTIGATION CURRENTLY UNDERWAY.
Description of Event or Problem · 1
IT WAS REPORTED THAT UPON A SCHEDULED RETRIEVAL OF AN IVC FILTER THAT HAD BEEN IMPLANTED FOR SIX YEARS, IT WAS OBSERVED THAT TWO FILTER FEET WERE MISSING FROM THE FILTER. LOCATION OF THE FILTER FEET ARE UNK. NO REPORT OF PT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RECOVERY FILTER SYSTEM | DTK | BARD PERIPHERAL VASCULAR, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |