BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD IT IS THE AFFIRM VPIII

    MDR report key: 23830116 · Received December 17, 2025

    Report

    Report Number
    MW5180711
    Event Type
    Malfunction
    Date Received
    December 17, 2025
    Date of Event
    December 4, 2025
    Report Date
    December 11, 2025
    Manufacturer
    BECTON DICKINSON CARIBE LTD.
    Product Code
    LIO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DURING SWABBING FOR SPECIMEN COLLECTION, THE SWAB TIP BECAME SEPARATED FROM THE STICK. BD AFFIRM VPIII. REF 446255 LOT#: B03H100M EXP: 2026-01-31.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2038737 BD IT IS THE AFFIRM VPIII DEVICE, SPECIMEN COLLECTION LIO BECTON DICKINSON CARIBE LTD. 446255 B03H100M

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Female