FDA Adverse Event
Malfunction
Summary report: N
RELI QUINCKE POINT SPINAL NEEDLE
MDR report key: 6423799
·
Received March 22, 2017
Report
- Report Number
- 1058382-2017-00003
- Event Type
- Malfunction
- Date Received
- March 22, 2017
- Report Date
- March 22, 2017
- Manufacturer
- DR. JAPAN CO. LTD.
- Product Code
- BSP
- UDI-DI
- 00386120006758
- Product Problem
- Yes
- Report Source
- Distributor report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THE STYLET OF THE NEEDLE IS STICKING; BEING DIFFICULT TO REMOVE FROM THE NEEDLE HUB WITH THE USE OF ONE HAND.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 208235 | RELI QUINCKE POINT SPINAL NEEDLE | SPINAL NEEDLE | BSP | DR. JAPAN CO. LTD. | 60201AV | 00386120006758 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |