FDA Adverse Event
Malfunction
Summary report: N
200594-6F 5 5 5 170 PENT JOS EZ
MDR report key: 280277
·
Received May 18, 2000
Report
- Report Number
- 1313046-2000-00005
- Event Type
- Malfunction
- Date Received
- May 18, 2000
- Date of Event
- April 26, 2000
- Report Date
- May 1, 2000
- Manufacturer
- C.R. BARD, INC. (GLENS FALLS)
- Product Code
- DRF
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
WHEN PROCEDURE WAS FINISHED/NOTICED THE 5TH ELECTRODE WAS MISSING. UPON VISUAL INSPECTION BY SALES REP THE ELECTRODE WAS STILL ATTACHED BUT HAD MOVED. THEY COULD NOT BE SURE IF THE ELECTRODE WAS IN PLACE BEFORE THEY STARTED THE PROCEDURE. BARE WIRE WAS STICKING OUT OF THE CATHETER WHEN PROCEDURE WAS COMPLETED. THE DOCTOR WAS NOT CONCERNED. THE DISPLAY WAS GOOD. THERE WAS NO PT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 200594-6F 5 5 5 170 PENT JOS EZ | 121070269-WOVEN DIAG MULTIPOLE | DRF | C.R. BARD, INC. (GLENS FALLS) | * | 07AK1713 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |