BEUDAMED
    FDA Adverse Event Other Summary report: N

    INDEFLATER

    MDR report key: 572932 · Received February 2, 2005

    Report

    Report Number
    572932
    Event Type
    Other
    Date Received
    February 2, 2005
    Date of Event
    December 9, 2004
    Report Date
    February 2, 2005
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    MAV
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE EVENT INVOLVES A PATIENT THAT HAD A MALFUNCTIONING LEFT FISTULA AND WAS UNDERGOING AV,ARTERIAL VENOUS, FISTULOGRAM. THERE WAS AN AIR LEAK AROUND THE RUBBER SEAL OF THE DISPOSABLE INFLATION DEVICE KIT USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INDEFLATER DISPOSABLE INFLATION DEVICE KIT MAV BARD ACCESS SYSTEMS MX30 51JOG039

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR