FDA Adverse Event
Malfunction
Summary report: N
BD 10ML SYRINGE LUER-LOK TIP 10ML SYRINGE
MDR report key: 15216853
·
Received August 11, 2022
Report
- Report Number
- MW5111442
- Event Type
- Malfunction
- Date Received
- August 11, 2022
- Date of Event
- August 3, 2022
- Report Date
- August 3, 2022
- Manufacturer
- BECTON DICKINSON AND COMPANY
- Product Code
- FMF
- UDI-DI
- 00382903029952
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- TX, US
- Reporter Occupation
- RISK MANAGER
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
IMAGING TECHNOLOGIST OPENED SEALED PACKAGE CONTAINING BD 10ML SYRINGE LUER-LOK TIP SYRINGE LOT# 1111465, EXP DATE: 03/31/2026, # (B)(4) AND DREW UP MEDICATION INTO SYRINGE, TECHNOLOGIST NOTICED FOREIGN BODY / DEBRIS FLOATING INSIDE CHAMBER OF SYRINGE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 326484 | BD 10ML SYRINGE LUER-LOK TIP 10ML SYRINGE | SYRINGE, PISTON | FMF | BECTON DICKINSON AND COMPANY | 302995 | 111465 | 00382903029952 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |