BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIX2VIAL

    MDR report key: 17370066 · Received July 21, 2023

    Report

    Report Number
    17370066
    Event Type
    Malfunction
    Date Received
    July 21, 2023
    Date of Event
    July 14, 2023
    Report Date
    July 19, 2023
    Manufacturer
    CSL BEHRING LLC
    Product Code
    LHI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    A NURSE ATTACHED THE VIAL ADAPTERS THAT COME WITH THE MEDICATION TO THE VIALS AND THEN CONNECTED THE VIALS PER THE MFG INSTRUCTIONS. THE ADAPTERS ARE SUPPOSED TO FACILITATE THE TRANSFER OF THE DILUENT TO THE DRUG FOR RECONSTITUTION ONCE THE VIALS ARE CONNECTED. THE DILUENT DID NOT TRANSFER TO THE MEDICATION VIAL. THE ADAPTER SYSTEM DID NOT WORK. DRUG: KCENTRA 800-1240 IU VIAL, MFG: CLS BEHRING LLC, NDC: 63833-0387-02, LOT ON POWDER VIAL: P100503324 EXP: 5/20/25, LOT ON DILUENT VIAL: P100491458 EXP: 10/12/27.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2107646 MIX2VIAL SET, I.V. FLUID TRANSFER LHI CSL BEHRING LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown