FDA Adverse Event
Malfunction
Summary report: N
BD INSYTE AUTOGUARD
MDR report key: 20245620
·
Received September 18, 2024
Report
- Report Number
- 20245620
- Event Type
- Malfunction
- Date Received
- September 18, 2024
- Date of Event
- June 3, 2024
- Report Date
- June 6, 2024
- Manufacturer
- BECTON, DICKINSON AND COMPANY
- Product Code
- FOZ
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- NY
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
THE IV CATHETER WAS BENT WHEN IT WAS TAKEN OUT OF THE PACKAGE. IT WAS A 20 GAUGE, LOT # 4102957.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1236428 | BD INSYTE AUTOGUARD | CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS | FOZ | BECTON, DICKINSON AND COMPANY | 4102957 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |