FDA Adverse Event
Malfunction
Summary report: N
BD NEXIVA, BD Q-SYTE
MDR report key: 21262964
·
Received January 29, 2025
Report
- Report Number
- 21262964
- Event Type
- Malfunction
- Date Received
- January 29, 2025
- Date of Event
- January 21, 2025
- Report Date
- January 23, 2025
- Manufacturer
- BECTON, DICKINSON AND COMPANY
- Product Code
- FOZ
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- UT
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
REGISTERED NURSE (RN) WENT TO PLACE PIV WITH NEXIVA 24 G. X 0.75 IN. PERIPHERAL INTRAVENOUS (PIV) WAS SUCCESSFULLY PLACED, BUT WHEN RN WENT TO FLUSH THE LINE, THE "PIGTAIL" WAS LEAKING "EVERYWHERE". RN REMOVED THE PIV AND SUCCESSFULLY RESTARTED NEW PIV.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1995054 | BD NEXIVA, BD Q-SYTE | CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS | FOZ | BECTON, DICKINSON AND COMPANY | 383531 | 4330298 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Female |