FDA Adverse Event
Malfunction
Summary report: N
PENUMBRA ASPIRATION PUMP
MDR report key: 1830725
·
Received March 15, 2010
Report
- Report Number
- 3005168196-2010-00194
- Event Type
- Malfunction
- Date Received
- March 15, 2010
- Date of Event
- August 12, 2008
- Report Date
- August 12, 2008
- Manufacturer
- PENUMBRA, INC.
- Product Code
- BTA
- PMA / PMN Number
- K051758
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS MDR IS BEING FILED AS PART OF THE REMEDIATION ACTION TAKEN AS PER PENUMBRA FEBRUARY 2010 UPDATE TO THE FDA WARNING LETTER DATED DECEMBER 31, 2009.
Description of Event or Problem · 1
THE PLASTIC FILTER WAS STUCK TO THE METAL THREADS ON THE PUMP HOUSING. WHEN THE TECH TRIED TO REMOVE THE FILTER, THE METAL THREADS COMPLETELY SEPARATED FROM THE PUMP HOUSING. THE METAL THREADS COULD NOT BE REALIGNED WITH THE SYSTEM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PENUMBRA ASPIRATION PUMP | POWERED SUCTION PUMP | BTA | PENUMBRA, INC. | 20060613016 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |