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