FDA Adverse Event
Malfunction
Summary report: N
MAGNUM DISPOSABLE NEEDLES
MDR report key: 1213198
·
Received October 22, 2008
Report
- Report Number
- 2020394-2008-00296
- Event Type
- Malfunction
- Date Received
- October 22, 2008
- Date of Event
- September 24, 2008
- Report Date
- September 24, 2008
- Manufacturer
- BARD PERIPHERAL VASCULAR, INC.
- Product Code
- FCG
- PMA / PMN Number
- K934370
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HISTORY RECORDS WERE REVIEWED AND IT WAS CONFIRMED THAT THE LOT MET ALL RELEASE CRITERIA. THE SAMPLE WAS RECEIVED AT MANUFACTURING SITE, AND THE INVESTIGATION IS UNDERWAY.
Description of Event or Problem · 1
IT WAS REPORTED BY THE USER FACILITY THAT THE SAMPLE NOTCH OF A BIOPSY INSTRUMENT WAS ALLEGEDLY EXPOSED AND COULD NOT CUT AND REMOVE THE TISSUE SAMPLE. NO PT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MAGNUM DISPOSABLE NEEDLES | FCG | BARD PERIPHERAL VASCULAR, INC. | PERF0404 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |