FDA Adverse Event
Malfunction
Summary report: N
PENUMBRA SYSTEM ASPIRATION TUBING
MDR report key: 1842608
·
Received September 1, 2010
Report
- Report Number
- 3005168196-2010-00596
- Event Type
- Malfunction
- Date Received
- September 1, 2010
- Date of Event
- August 11, 2010
- Report Date
- August 11, 2010
- Manufacturer
- PENUMBRA, INC.
- Product Code
- NRY
- PMA / PMN Number
- K072718
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WY, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE PRODUCT WAS NOT RETURNED FOR EVALUATION. WITHOUT THE RETURN OF THE DEVICE, THE ROOT CAUSE OF THE PROBLEM CANNOT BE DETERMINED.
Description of Event or Problem · 1
THE TECHNICIAN OPENED THE PACKAGE AND SAID THE CLEAR CONNECTOR WAS CRACKED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PENUMBRA SYSTEM ASPIRATION TUBING | PERCUTANEOUS CATHETER | NRY | PENUMBRA, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |