FDA Adverse Event
Malfunction
Summary report: N
2PC VSYS/PRT/LOCKS 4NDL LW PFL
MDR report key: 971141
·
Received December 26, 2007
Report
- Report Number
- 1219930-2007-00880
- Event Type
- Malfunction
- Date Received
- December 26, 2007
- Date of Event
- November 12, 2007
- Report Date
- November 14, 2007
- Manufacturer
- NORTH HAVEN - USS
- Product Code
- LJT
- PMA / PMN Number
- K952748
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
SEX: UNK. PROCEDURE: UNK. ACCORDING TO THE REPORTER: THE CATHETER BROKE PRIOR TO BEING IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 2PC VSYS/PRT/LOCKS 4NDL LW PFL | NONE | LJT | NORTH HAVEN - USS | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK YR |