BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMICI SWIRLER WITH MOUTHPIECE

    MDR report key: 3020781 · Received March 21, 2013

    Report

    Report Number
    MW5029457
    Event Type
    Malfunction
    Date Received
    March 21, 2013
    Date of Event
    February 28, 2013
    Report Date
    March 12, 2013
    Manufacturer
    AMICI INC
    Product Code
    CAF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    TECHNICIAN REPORTS WHILE ADDING DTPA TO THE SWIRLER AEROSOL DELIVERY SYSTEM IT LEAKED OUT THE BOTTOM OF THE SYSTEM. THERE WAS LOCAL CONTAMINATION PROPER PROTOCOL AND NOTIFICATION WAS DONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116922 AMICI SWIRLER WITH MOUTHPIECE AEROSOL DELIVERY AND TRAPPING SYSTEM CAF AMICI INC 120423L

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other