BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MCKESSON BRAND

    MDR report key: 23889683 · Received December 24, 2025

    Report

    Report Number
    1451040-2025-00123
    Event Type
    Malfunction
    Date Received
    December 24, 2025
    Date of Event
    November 26, 2025
    Report Date
    December 24, 2025
    Manufacturer
    LIFELONG MEDITECH PRIVATE LIMITED
    Product Code
    FMF
    UDI-DI
    10612479275604
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE NEEDLE DOES NOT STAY PROPERLY ON THE SYRINGE AND COMES OFF. ON (B)(6) 2025, THE CUSTOMER RESPONDED TO THE PROBING QUESTIONS AND CONFIRMED THAT THERE WERE NO PATIENT INJURIES; HOWEVER, MEDICATION LEAKAGE DID OCCUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2516988 MCKESSON BRAND SYRINGE, LS W/O NDL 1CC FMF LIFELONG MEDITECH PRIVATE LIMITED 032501-K 10612479275604

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown