BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MCKESSON BRAND

    MDR report key: 22871014 · Received August 22, 2025

    Report

    Report Number
    1451040-2025-00076
    Event Type
    Malfunction
    Date Received
    August 22, 2025
    Date of Event
    August 4, 2025
    Report Date
    August 22, 2025
    Manufacturer
    LIFELONG MEDITECH PRIVATE LIMITED
    Product Code
    FMF
    UDI-DI
    10612479206974
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED RESISTANCE WHEN PULLING THE SYRINGE PLUNGER PAST THE 2.5 ML MARK, DESCRIBING IT AS A "SPEED BUMP" SENSATION. THIS CAUSED LEAKAGE DURING IM VITAMIN DRAWING, RESULTING IN FLUID ON THE PLUNGER AND THE STAFF MEMBER'S HAND. NO INFORMATION WAS RECEIVED REGARDING ANY SERIOUS INJURY AS A RESULT OF THIS PRODUCT ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    209576 MCKESSON BRAND SYRINGE, LL 3CC FMF LIFELONG MEDITECH PRIVATE LIMITED 032503-AV 10612479206974

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown