FDA Adverse Event
Malfunction
Summary report: N
BD 60ML SYRINGE
MDR report key: 5929549
·
Received August 31, 2016
Report
- Report Number
- MW5064561
- Event Type
- Malfunction
- Date Received
- August 31, 2016
- Date of Event
- August 26, 2016
- Report Date
- August 31, 2016
- Manufacturer
- BD
- Product Code
- FMI
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- WA, US
- Reporter Occupation
- PHARMACIST
Narratives
Description of Event or Problem · 1
I HAVE A PRODUCT QUALITY CONCERN. BD 60ML SYRINGE LUER-LOK TIP REF # (B)(4). LOT 6132833. EXP 2021-05. DIR PRESENT INSIDE PACKAGING. I HAVE THE PRODUCT. DIAGNOSIS OR REASON FOR USE: DURING PHARMACY COMPOUNDING STERILE PREPARATIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 571116 | BD 60ML SYRINGE | BD 60ML SYRINGE | FMI | BD | 6132833 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |