FDA Adverse Event
Malfunction
Summary report: N
AIR ASPIRATOR NEEDLE
MDR report key: 1172520
·
Received September 22, 2008
Report
- Report Number
- 1625519-2008-00004
- Event Type
- Malfunction
- Date Received
- September 22, 2008
- Date of Event
- August 26, 2008
- Report Date
- September 18, 2008
- Manufacturer
- NOVOSCI, INC.
- Product Code
- GAA
- PMA / PMN Number
- 801393
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
DEVICE NOT YET RECEIVED BUT HAS BEEN SHIPPED BY COMPLAINANT. EVALUATION ANTICIPATED UPON RECEIVING.
Description of Event or Problem · 1
UPON STICKING NEEDLE INTO AORTA, NEEDLE BENDS ALLOWING AORTIC TISSUE TO GET STUCK IN NEEDLE, BLOCKING THE FLOW.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AIR ASPIRATOR NEEDLE | AIR ASPIRATOR NEEDLE | GAA | NOVOSCI, INC. | 288656 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |