BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTERIAL CANNULA

    MDR report key: 1812277 · Received August 16, 2010

    Report

    Report Number
    1828100-2010-01163
    Event Type
    Malfunction
    Date Received
    August 16, 2010
    Date of Event
    June 18, 2010
    Report Date
    August 16, 2010
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    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

    DEVICE EVAL ANTICIPATED, BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    DURING USE OF THE DEVICE FOR A SURGICAL PROCEDURE, THE USER REPORTED THE CAP ON THE CANNULA WAS DIFFICULT TO REMOVE. THE USER USED FORCEPS TO REMOVE THE CAP. THE CANNULA WAS USED TO CONCLUDE THE PROCEDURE. THE USER REPORTED THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WERE NO ADVERSE CONSEQUENCES TO THE PT AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTERIAL CANNULA CANNULA AND CATHETER DWF TERUMO CARDIOVASCULAR SYSTEMS CORP. CV-6392 0540709

    Patients

    Seq Age Sex Outcome Treatment
    1