FDA Adverse Event
Malfunction
Summary report: N
BIOPSY INSTRUMENT
MDR report key: 1638276
·
Received March 16, 2010
Report
- Report Number
- 1036710-2010-00010
- Event Type
- Malfunction
- Date Received
- March 16, 2010
- Date of Event
- February 22, 2010
- Report Date
- February 22, 2010
- Manufacturer
- ANGIOTECH, MEDICAL DEVICE TECHNOLOGIES
- Product Code
- KNW
- PMA / PMN Number
- K980226
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE PACKAGED DEVICE RETURNED HAS A SMALL HOLE ON THE POLY SIDE OF THE POUCH. THE PLACEMENT OF THE HOLE IS TOWARDS THE TOP OF THE POUCH NEAR THE HANDLE. THE SAMPLE HAS BEEN REVIEWED AND THERE ARE NO SHARP EDGES ON THE DEVICE TO CAUSE A HOLE WITHOUT A HARD IMPACT ON THE POUCH. NO DEFECTS OR DEVIATIONS WERE NOTED DURING THE BATCH RECORD REVIEW. THEREFORE, IT IS LIKELY THIS DEFECT WAS CAUSED BY DAMAGE WHICH OCCURRED DURING SHIPMENT TO THE CUSTOMER, OR IMPROPER HANDLING BEYOND OUR MANUFACTURING CONTROL.
Description of Event or Problem · 1
THE POUCH IS DRILLED. THERE IS A HOLE IN THE POUCH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BIOPSY INSTRUMENT | PRO-MAG BIOPSY INSTRUMENT | KNW | ANGIOTECH, MEDICAL DEVICE TECHNOLOGIES | 765014100 | 93491YG3 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |