BEUDAMED
    FDA Adverse Event Injury Summary report: N

    23GX 1 1/2' SAFETY NEEDLE

    MDR report key: 20734692 · Received November 19, 2024

    Report

    Report Number
    MW5162674
    Event Type
    Injury
    Date Received
    November 19, 2024
    Date of Event
    November 3, 2024
    Report Date
    November 17, 2024
    Manufacturer
    BHSUPPLIES / ANREL DISTRIBUTION LLC
    Product Code
    FMF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    MY HUSBAND PURCHASED 23GX1 1/2' SAFETY NEEDLES FROM (B)(6) ON AMAZON. I AM A NATIONALLY CERTIFIED MEDICAL ASSISTANT WITH OVER 20 YEARS EXPERIENCE PROVIDING INJECTIONS. I HAVE USED THESE NEEDLES 3 TIMES TO ADMINISTER MY HUSBAND'S IM MEDICATION. EACH TIME THE SAFETY DEVICE DID NOT ACTIVATE. WHEN ATTEMPTING THE SINGLE FINGER ACTION TO CLOSE THE SAFETY SHEATH OVER THE NEEDLE IT DOES NOT SNAP SHUT. THE NEEDLE JUST BENDS. THIS 3RD TIME RESULTED IN AN ACCIDENTAL FINGER STICK. WHILE I AM HIV NEGATIVE, MY HUSBAND IS NOT. THESE NEEDLES ARE NOT COMPLIANT WITH SAFETY STANDARDS AND NEED TO BE REMOVED FROM THE MARKET. I HAVE AN UPCOMING APPOINTMENT FOR MEDICAL TESTING. REFERENCE REPORT #MW5162675, #MW5162676.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1971123 23GX 1 1/2' SAFETY NEEDLE SYRINGE, PISTON FMF BHSUPPLIES / ANREL DISTRIBUTION LLC SN23-15 231001

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Male Other BIKTARVY| TESTOSTERONE