BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATHETER AND CANNULA

    MDR report key: 3101771 · Received May 3, 2013

    Report

    Report Number
    1828100-2013-00485
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    April 1, 2013
    Report Date
    April 11, 2013
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEM CORP
    Product Code
    DWF
    PMA / PMN Number
    K890024
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SALE REPRESENTATIVE, THAT WHEN THE CUSTOMER SCANNED THE ARTERIAL CANNULA (B)(4) BARCODE (8MM SOFT FLOW) AND IT SCANNED IN A (B)(4) (7MM SOFT FLOW). NO OTHER DETAILS REGARDING THE NATURE OF THIS EVENT WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195171 CATHETER AND CANNULA DWF TERUMO CARDIOVASCULAR SYSTEM CORP 4951

    Patients

    Seq Age Sex Outcome Treatment
    1