BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIAL ADAPTER MCKESSON CLAVE

    MDR report key: 23077656 · Received September 17, 2025

    Report

    Report Number
    MW5176213
    Event Type
    Malfunction
    Date Received
    September 17, 2025
    Report Date
    September 13, 2025
    Manufacturer
    MEDICAL SPECIALTIES DISTRIBUTORS, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    003
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    PATIENT STATED THEY SEEM TO BE HAVING TROUBLE USING THE CLAVE ADAPTERS AND HAVE SPILLED TWO BOTTLES OF MEDICATION ALREADY. NO DELAY IN INFUSION, PATIENT STILL HAS MEDICATION ON HAND, THE VIALS WILL BE REPLACED. NO FURTHER DETAILS PROVIDED. UNKNOWN IF PATIENT EXPERIENCED AN ADVERSE EVENT, MISSED DOSE, OR IF PRODUCT AVAILABLE FOR RETURN. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2577542 VIAL ADAPTER MCKESSON CLAVE SET, ADMINISTRATION, INTRAVASCULAR FPA MEDICAL SPECIALTIES DISTRIBUTORS, INC. MS994

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female FLOLAN STERILE DILUENT (50ML).| OPSYNVI.| TREPROSTINIL MDV.| UNKNOWN DRUG, 71.8 NG NANOGRAM(S).| WINREVAIR SDV.