BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BODYGUARD MICROSET WITH FILTER TUBING

    MDR report key: 3866572 · Received May 30, 2014

    Report

    Report Number
    MW5036466
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    May 24, 2014
    Report Date
    May 30, 2014
    Manufacturer
    CME AMERICA, LLC
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    BODYGUARD TUBING REF (B)(4) LEAKS FROM THE FILTERED END. PT REPORTED BAG LEAKAGE ON (B)(6) 2014. BAG WAS RETRIEVED FROM PT'S HOME AND EXAMINED. IT WAS FOUND THAT THE LEAKAGE WAS FROM THE FILTERED PART OF THE CME BODYGUARD TUBING REF (B)(4) ATTACHED. (B)(4)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319369 BODYGUARD MICROSET WITH FILTER TUBING BODYGUARD FILTER TUBING FPA CME AMERICA, LLC A120-160XSFK 1449000-14/85

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR