FDA Adverse Event
Malfunction
Summary report: N
BECTON, DICKINSON AND COMPANY
MDR report key: 9947868
·
Received April 10, 2020
Report
- Report Number
- 9947868
- Event Type
- Malfunction
- Date Received
- April 10, 2020
- Date of Event
- March 1, 2020
- Report Date
- March 24, 2020
- Manufacturer
- BECTON, DICKINSON AND COMPANY
- Product Code
- FMF
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- AZ
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
REPORT SUBMITTED FOR TRACKING PURPOSES ONLY-DO NOT HAVE LOT, SERIAL OR MODEL NUMBERS. NYICU (NURSERY INTENSIVE CARE UNIT) RN NOTED THAT DOPAMINE IN 3ML (BD) SYRINGE CONNECTED TO BUFF CAP WAS LEAKING AT CONNECTION SITE. NO HARM TO INFANT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 412051 | BECTON, DICKINSON AND COMPANY | SYRINGE, PISTON | FMF | BECTON, DICKINSON AND COMPANY |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |