FDA Adverse Event
Malfunction
Summary report: N
ACKERMANN BONE BIOPSY NEEDLE SET
MDR report key: 2559711
·
Received April 19, 2012
Report
- Report Number
- 1820334-2012-00202
- Event Type
- Malfunction
- Date Received
- April 19, 2012
- Date of Event
- March 21, 2012
- Report Date
- March 21, 2012
- Manufacturer
- COOK INC
- Product Code
- DWO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- EI
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). EVENT EVALUATION: STILL UNDER INVESTIGATION.
Description of Event or Problem · 1
END OF NEEDLE BROKE. SPIKE PART OF NEEDLE REMAINED STUCK IN CHILD AND NEEDED A LOT OF FORCE TO REMOVE. THIS WAS THE SECOND TIME IN LESS THAN A WEEK THIS OCCURRED. NO PATIENT OUTCOME HAS BEEN PROVIDED BY THE REPORTER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACKERMANN BONE BIOPSY NEEDLE SET | DWO NEEDLE, BIOPSY, CARDIOVASCULAR | DWO | COOK INC | NA | F2705338 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |