FDA Adverse Event
Malfunction
Summary report: N
BD INSTYE AUTOGUARD
MDR report key: 562922
·
Received September 10, 2003
Report
- Report Number
- 562922
- Event Type
- Malfunction
- Date Received
- September 10, 2003
- Date of Event
- September 1, 2003
- Report Date
- September 10, 2003
- Manufacturer
- BD MEDICAL SYSTEMS
- Product Code
- FOZ
- 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 INSTYE AUTOGUARD | INSYTE AUTOGUARD 20GA - 1.00IN 1.1 X 25MM 65ML/MIN | FOZ | BD MEDICAL SYSTEMS | 381433 | 3059657 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |