BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ENDO SHEATH

    MDR report key: 1151984 · Received September 8, 2008

    Report

    Report Number
    MW5008226
    Event Type
    Malfunction
    Date Received
    September 8, 2008
    Date of Event
    July 28, 2008
    Report Date
    August 29, 2008
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    RN ATTEMPTED TO INSERT INNER SHEATH INTO CATHETER AND THE CATHETER WAS OCCLUDED. THE SHEATH COULD NOT BE INSERTED, AND THE CATHETER COULDN'T BE FLUSHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TERUMO ENDO SHEATH ENDOVASCULAR SHEATH DYB TERUMO CARDIOVASCULAR SYSTEMS CORP. * KF07

    Patients

    Seq Age Sex Outcome Treatment
    1