BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MCKESSON BRAND

    MDR report key: 23892267 · Received December 25, 2025

    Report

    Report Number
    1451040-2025-00127
    Event Type
    Malfunction
    Date Received
    December 25, 2025
    Date of Event
    December 8, 2025
    Report Date
    December 25, 2025
    Manufacturer
    LIFELONG MEDITECH PRIVATE LIMITED
    Product Code
    FMF
    UDI-DI
    10612479207001
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT FLUORESCEIN DYE LEAKED FROM THE SYRINGE DURING USE, SPECIFICALLY FROM THE PLUNGER SIDE. 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
    2329982 MCKESSON BRAND SYRINGE, LL 5CC FMF LIFELONG MEDITECH PRIVATE LIMITED 042505-U 10612479207001

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown