FDA Adverse Event
Malfunction
Summary report: N
BD SAFETY-LOK
MDR report key: 20343409
·
Received October 1, 2024
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Report
- Report Number
- 20343409
- Event Type
- Malfunction
- Date Received
- October 1, 2024
- Date of Event
- June 27, 2024
- Report Date
- June 28, 2024
- Manufacturer
- BECTON, DICKINSON AND COMPANY
- Product Code
- FMI
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- MI
- Reporter Occupation
- 003
Narratives
Description of Event or Problem · 0
GAVE A HIB SHOT TO 2-MONTH-OLD. WHEN PULLING THE NEEDLE OUT OF THE LEFT THIGH, THE SYRINGE AND THE PLASTIC BASE OF THE NEEDLE CAME UP IN MY HAND, BUT THE METAL NEEDLE STAYED IN HIS THIGH. PULLED THE METAL NEEDLE OUT WITH MY GLOVED HAND.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1916070 | BD SAFETY-LOK | NEEDLE, HYPODERMIC, SINGLE LUMEN | FMI | BECTON, DICKINSON AND COMPANY | 305901 | 4075988 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |