FDA Adverse Event
Malfunction
Summary report: N
BD NANO 2NDG PEN NEEDLE 32GX4MM
MDR report key: 18536941
·
Received January 17, 2024
Report
- Report Number
- MW5150501
- Event Type
- Malfunction
- Date Received
- January 17, 2024
- Date of Event
- January 12, 2024
- Report Date
- January 12, 2024
- Manufacturer
- EMBECTA MEDICAL II LLC
- Product Code
- FMI
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Occupation
- PHARMACIST
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
MEMBER CALLED MAIL ORDER PHARMACY TO REPORT A LARGE NUMBER OF HIS BD NANO 2ND GEN 32GX4MM PEN NEEDLES ARE EITHER ALREADY BENT (NEW FROM BOX) OR BEND TO A 90 DEGREE ANGLE AFTER HIS INJECTION. HE STATES THIS HAPPENS ALMOST EVERY OTHER DAY AND NEVER HAPPENED WITH HIS NOVOFINE PEN NEEDLES. HE CHECKED THE NEEDLE BEFORE EACH INJECTION AND SEVERAL HAVE BEEN SLIGHTLY BENT BEFORE 1ST USE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1774176 | BD NANO 2NDG PEN NEEDLE 32GX4MM | NEEDLE, HYPODERMIC, SINGLE LUMEN | FMI | EMBECTA MEDICAL II LLC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Male |