BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTERIAL CANNULA

    MDR report key: 2062326 · Received April 12, 2011

    Report

    Report Number
    1828100-2011-00906
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    March 8, 2011
    Report Date
    April 12, 2011
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DWF
    PMA / PMN Number
    K930620
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL IN PROGRESS, BUT NOT YET CONCLUDED.

    Description of Event or Problem · 1

    THE USER REPORTED THAT VISIBLE NARROWING OF THE CANNULA TUBE WAS DETECTED. THE USER ALSO REPORTED THAT NO PT WAS INVOLVED AND THE EVENT OCCURRED PRIOR TO USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTERIAL CANNULA CANNULA AND CATHETER DWF TERUMO CARDIOVASCULAR SYSTEMS CORP. 4888 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1