FDA Adverse Event
Malfunction
Summary report: N
BECTON, DICKINSON AND COMPANY
MDR report key: 18562406
·
Received January 23, 2024
Report
- Report Number
- 18562406
- Event Type
- Malfunction
- Date Received
- January 23, 2024
- Date of Event
- January 9, 2024
- Report Date
- January 11, 2024
- Manufacturer
- BECTON, DICKINSON AND COMPANY
- Product Code
- JKA
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- OH
- Reporter Occupation
- RISK MANAGER
- Health Professional
- N
Narratives
Description of Event or Problem · 0
BD VACUTAINER, GREEN TOP, DID NOT FILL WITH BLOOD. TWO ADDITIONAL GREEN TOPS USED AND WOULD NOT FILL. THE 4TH GREEN TOP FILLED WITH BLOOD AND PROCEEDING VACUTAINERS FILLED WITHOUT DIFFICULTY. NO KNOWN HARM TO PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 839434 | BECTON, DICKINSON AND COMPANY | TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION | JKA | BECTON, DICKINSON AND COMPANY | 367884 | 3257745 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |