FDA Adverse Event
Other
Summary report: N
BD INSYTE AUTOGUARD SHIELDED IV CATHETER
MDR report key: 17780486
·
Received September 20, 2023
Report
- Report Number
- 17780486
- Event Type
- Other
- Date Received
- September 20, 2023
- Date of Event
- August 15, 2023
- Report Date
- August 23, 2023
- Manufacturer
- BECTON, DICKINSON AND COMPANY
- Product Code
- FOZ
- Report Source
- User Facility report
- Reporter Location
- CA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
INSERTED 22# PIV. UNABLE TO RETRACT NEEDLE OR ADVANCE CATHETER OFF OF NEEDLE. HAD TO TAKE ENTIRE IV OUT. UPON REMOVAL, ATTEMPTED AGAIN TO RETRACT NEEDLE AND NEEDLE WOULD NOT RETRACT. PUT ENTIRE UNIT INTO SHARPS BIN. BD INSYTE AUTOGUARD BV, 22GA X 1.00IN, LOT#3075853, EXP: 2026-02-28.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 84482 | BD INSYTE AUTOGUARD SHIELDED IV CATHETER | CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS | FOZ | BECTON, DICKINSON AND COMPANY | 3075853 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |