FDA Adverse Event
Malfunction
Summary report: N
BD INSYTE AUTOGUARD 18 GA 1.16 IN
MDR report key: 563328
·
Received September 12, 2003
Report
- Report Number
- 563328
- Event Type
- Malfunction
- Date Received
- September 12, 2003
- Date of Event
- August 1, 2003
- Report Date
- September 12, 2003
- Manufacturer
- BD MEDICAL SYSTEMS
- Product Code
- FMI
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- NJ, US
- Reporter Occupation
- RISK MANAGER
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BD INSYTE AUTOGUARD 18 GA 1.16 IN | NEEDLE | FMI | BD MEDICAL SYSTEMS | * | 2148198 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |