FDA Adverse Event
Malfunction
Summary report: N
BD PEN NED UF NANO 4MM 90'S
MDR report key: 6102205
·
Received November 10, 2016
Report
- Report Number
- MW5066022
- Event Type
- Malfunction
- Date Received
- November 10, 2016
- Date of Event
- May 1, 2016
- Report Date
- November 4, 2016
- Manufacturer
- BD
- Product Code
- FMI
- UDI-DI
- 08290320883
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- TN, US
- Reporter Occupation
- PHARMACIST
Narratives
Description of Event or Problem · 1
KINKS IN NEEDLE INSULIN NOT DELIVERED. IS THE PRODUCT COMPOUNDED: NO. IS THE PRODUCT OVER-THE-COUNTER: NO.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 744437 | BD PEN NED UF NANO 4MM 90'S | BD PEN NED UF NANO 4MM 90'S | FMI | BD | 6089632 | 08290320883 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR |