BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANCE MEDICAL DESIGNS VIAL DECANTER

    MDR report key: 2296532 · Received October 10, 2011

    Report

    Report Number
    MW5022607
    Event Type
    Malfunction
    Date Received
    October 10, 2011
    Date of Event
    October 7, 2011
    Report Date
    October 10, 2011
    Manufacturer
    ADVANCE MEDICAL DESIGNS, INC.
    Product Code
    KPE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PROBLEM: THE PUNCTURE PORTION OF THE VIAL DECANTER THAT PIERCES THE VIAL OF MEDICATION IS CAUSING SMALL PIECES OF THE RUBBER FROM THE MEDICATION VIAL TO BREAK OFF AND FLOAT IN THE MEDICATION TO BE ADMINISTERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVANCE MEDICAL DESIGNS VIAL DECANTER VIAL DECANTER KPE ADVANCE MEDICAL DESIGNS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1