FDA Adverse Event
Malfunction
Summary report: N
INTROCAN SAFETY
MDR report key: 4109327
·
Received September 3, 2014
Report
- Report Number
- 4109327
- Event Type
- Malfunction
- Date Received
- September 3, 2014
- Report Date
- September 3, 2014
- Manufacturer
- B. BRAUN MEDICAL INDUSTRIES SDN. BHD.
- Product Code
- FOZ
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- IL, US
Narratives
Description of Event or Problem · 1
THE PASSIVE SAFETY DEVICE DID NOT FULLY ENGAGE UPON RETRACTION. THE NURSE WAS STUCK BY THE NEEDLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 538704 | INTROCAN SAFETY | CATHETER | FOZ | B. BRAUN MEDICAL INDUSTRIES SDN. BHD. | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |