FDA Adverse Event
Malfunction
Summary report: N
INTROCAN SAFETY 2 IV CATHETER
MDR report key: 22954680
·
Received September 3, 2025
Report
- Report Number
- MW5175566
- Event Type
- Malfunction
- Date Received
- September 3, 2025
- Date of Event
- August 27, 2025
- Report Date
- August 28, 2025
- Manufacturer
- B. BRAUN MEDICAL INDUSTRIES SDN. BHD.
- Product Code
- FOZ
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- TX, US
- Reporter Occupation
- RISK MANAGER
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
THE METAL NEEDLE DISLODGED FROM THE PLASTIC PART YOU HOLD WITH YOUR HAND.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1734336 | INTROCAN SAFETY 2 IV CATHETER | CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS | FOZ | B. BRAUN MEDICAL INDUSTRIES SDN. BHD. | 25E05G8271 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 27 YR | Male |