BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BOSTON SCIENTIFIC

    MDR report key: 1321249 · Received February 17, 2009

    Report

    Report Number
    MW5010036
    Event Type
    Injury
    Date Received
    February 17, 2009
    Date of Event
    February 16, 2009
    Report Date
    February 17, 2009
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    KNT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CT, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ON ATTEMPTING TO PLACE DRAINAGE TUBE, FROM BOSTON SCIENTIFIC, UNABLE TO USE CATHETER DUE TO INNER LUMEN BEING BLOCKED BY WHITE PLASTIC. THIS HAS HAPPENED NUMEROUS TIMES IN PAST TWO MONTHS. OF NOTE, THE CATHETER HAS A TIP PROTECTER THAT SLIDES OUT OF THE TIP PRIOR TO USE. THE PROTECTER WAS FOUND TO BE SNAPPED OFF IN THE LUMEN WHILE STILL IN THE PACKAGING LEAVING THE LUMEN BLOCKED. THIS HAS HAPPENED TO NUMEROUS CATHETERS SIZES #10 FR AND #8 FR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOSTON SCIENTIFIC #10 FR ALL PURPOSE TT REGULAR FLEXIMA CATHETER SET KNT BOSTON SCIENTIFIC 9485168

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention