BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KCENTRA MIX2VIAL(TM)

    MDR report key: 24943284 · Received April 21, 2026

    Report

    Report Number
    MW5187079
    Event Type
    Malfunction
    Date Received
    April 21, 2026
    Date of Event
    April 13, 2026
    Report Date
    April 17, 2026
    Manufacturer
    CSL BEHRING LLC
    Product Code
    LHI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    MIX TO VIAL TRANSFER DEVICE DID NOT PROPERLY DISCONNECT FROM DEVICE. WHOLE STOPPER AND METAL RING AROUND VIAL PULLED OFF OF VIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1008469 KCENTRA MIX2VIAL(TM) SET, I.V. FLUID TRANSFER LHI CSL BEHRING LLC P100750335

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female