FDA Adverse Event
Malfunction
Summary report: N
ORIGEN REINFORCED DUAL LUMEN CATHETER
MDR report key: 8472101
·
Received April 2, 2019
Report
- Report Number
- 1646848-2019-00014
- Event Type
- Malfunction
- Date Received
- April 2, 2019
- Report Date
- April 1, 2019
- Manufacturer
- ORIGEN BIOMEDICAL, INC
- Product Code
- DWF
- PMA / PMN Number
- K113869
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- 003
Narratives
Description of Event or Problem · 1
CRUSHED CATHETER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 269420 | ORIGEN REINFORCED DUAL LUMEN CATHETER | VV ECMO CATHETER | DWF | ORIGEN BIOMEDICAL, INC | VV13F | M18285 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |