FDA Adverse Event
Summary report: N
BIOPINCE
MDR report key: 2075941
·
Received April 22, 2011
Report
- Report Number
- 2075941
- Date Received
- April 22, 2011
- Date of Event
- December 27, 2010
- Report Date
- April 22, 2011
- Manufacturer
- MEDICAL DEVICE TECHNOLOGIES, INC -ANGIOTECH GNW
- Product Code
- KNW
- Report Source
- User Facility report
- Reporter Location
- MO, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
A RADIOLOGIST WAS PERFORMING A CT-GUIDED NEEDLE BIOPSY OF LIVER. THE WRONG NEEDLE WAS GIVEN TO THE PHYSICIAN TO ATTACH TO THE BIOPSY INSTRUMENT. THE NEEDLE WAS TOO LONG AND WHEN IT WAS INSERTED IN THE LIVER PROGRESSED ALSO INTO THE KIDNEY CAUSING BLEEDING AND A SMALL HEMATOMA ON BOTH THE KIDNEY AND LIVER. RADIOLOGY NURSE CLAIMS THE PACKAGING IS TOO SMALL TO INDICATE WHAT NEEDLE TO USE FOR THE INSTRUMENT WHICH CAN LEAD TO USING THE WRONG SIZED NEEDLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BIOPINCE | BIOPSY INSTRUMENT AND NEEDLE | KNW | MEDICAL DEVICE TECHNOLOGIES, INC -ANGIOTECH GNW | 18G X 15CM | 00711ZUH & 010220EL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 45 YR |