BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENT CATHETER

    MDR report key: 1791515 · Received August 6, 2010

    Report

    Report Number
    1828100-2010-01103
    Event Type
    Malfunction
    Date Received
    August 6, 2010
    Date of Event
    July 22, 2010
    Report Date
    August 6, 2010
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
    Product Code
    DWF
    PMA / PMN Number
    K890024
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION IN PROGRESS, BUT NOT YET CONCLUDED.

    Description of Event or Problem · 1

    DURING INCOMING INSPECTION OF THE DEVICE, OUR FOREIGN CONSIGNEE REPORTED THE CATHETER WAS FLATTENED. NO OTHER DETAILS REGARDING THE NATURE OF THE EVENT WERE PROVIDED. SINCE THE EVENT OCCURRED DURING INCOMING INSPECTION OF THE DEVICE, THERE WAS NO PT INVOLVEMENT DURING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENT CATHETER CANNULA AND CATHETER DWF TERUMO CARDIOVASCULAR SYSTEMS CORPORATION CV-18080 0603425

    Patients

    Seq Age Sex Outcome Treatment
    1