BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 1.0ML 31G TW 6MM BLS 400 SG

    MDR report key: 21917845 · Received April 28, 2025

    Report

    Report Number
    21917845
    Event Type
    Malfunction
    Date Received
    April 28, 2025
    Date of Event
    April 2, 2025
    Report Date
    April 23, 2025
    Manufacturer
    EMBECTA MEDICAL II, LLC
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    INSULIN SYRINGE SAFETY GLIDE MECHANISM FELL OFF DURING ACTIVATION. INSULIN WAS ADMINISTERED PRIOR TO SAFETY FAILURE. NO NEEDLE STICKS OCCURRED FROM THE MALFUNCTION. MANUFACTURER RESPONSE FOR SYRINGE INSULIN 1ML, SYRINGE INSULIN 1ML 31GAX0.25I (PER SITE REPORTER). SENT EVENT DETAILS TO THE VENDOR, NOW WAITING FOR THEM TO SEND THE EVENT DETAILS TO THE MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1757723 SYRINGE 1.0ML 31G TW 6MM BLS 400 SG SYRINGE, PISTON FMF EMBECTA MEDICAL II, LLC 328446 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Female