BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SECURE

    MDR report key: 591948 · Received April 11, 2005

    Report

    Report Number
    MW1035163
    Event Type
    Malfunction
    Date Received
    April 11, 2005
    Date of Event
    March 30, 2005
    Report Date
    April 11, 2005
    Manufacturer
    THE METRIX CO.
    Product Code
    KPE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE SHRINK BAND ON THE INJECTION SITE COMES LOOSE WHEN SWABBING THE PORT WITH ALCOHOL. THIS ALLOWS THE SITE CAP TO COME OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SECURE EMPTY EVA CONTAINER KPE THE METRIX CO. 500 ML EVA CONT. 66410-13498

    Patients

    Seq Age Sex Outcome Treatment
    1 *