BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADD EASE BINARY CONNECTOR

    MDR report key: 376258 · Received February 7, 2002

    Report

    Report Number
    MW1024041
    Event Type
    Other
    Date Received
    February 7, 2002
    Date of Event
    December 17, 2001
    Report Date
    February 7, 2002
    Manufacturer
    B. BRAUN MEDICAL INC.
    Product Code
    LHI
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    ADD-EASE BINARY CONNECTOR FAILED ON 2 OCCASIONS. THE PREVIOUS DELIVERY OF MEDICATION ATTACHED TO ADD-EASE BINARY CONNECTORS (PROTONIX) WERE ACTIVATED ON ARRIVAL IN THE PT'S HOME. THIS TIME PT COULD ACTIVATE THE VIALS BUT COULD NOT GET THE FLUID OUT OF THE VIAL FOR INFUSION DUE TO DEFECTIVE PART (ADD-EASE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADD EASE BINARY CONNECTOR VIAL ADAPTER FOR IV ADMIXTURES LHI B. BRAUN MEDICAL INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other REPLACEMENT OF DEFECTIVE MEDICATION VIALS.