FDA Adverse Event
Malfunction
Summary report: N
BD 3ML SYRINGE LUER-LOK TIP
MDR report key: 7832222
·
Received August 29, 2018
Report
- Report Number
- MW5079484
- Event Type
- Malfunction
- Date Received
- August 29, 2018
- Date of Event
- August 23, 2018
- Report Date
- August 28, 2018
- Manufacturer
- BECTON DICKINSON AND COMPANY
- Product Code
- FMF
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
BD 3ML SYRINGE HAS A CRACK THAT RESULTED IN A SPLASH INCIDENT INVOLVING A STAFF WHEN PLUNGER WAS PUSHED DURING MEDICATION ADMINISTRATION BY MEDICAL ASSISTANT. NO OTHER SYRINGES WERE FOUND TO BE DEFECTIVE. REF 309657, LOT #8046992, EXP: 02/28/2023, MFR: BECTON DICKINSON AND COMPANY. MADE IN (B)(6). DATES OF USE: (B)(6) 2018.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 666652 | BD 3ML SYRINGE LUER-LOK TIP | SYRINGE, PISTON | FMF | BECTON DICKINSON AND COMPANY | 8046992 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |