BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFE-T PLUS THORA-PARA CATHETER DRAINAGE TRAY WITH 8 FR CATHETER

    MDR report key: 6056741 · Received October 26, 2016

    Report

    Report Number
    6056741
    Event Type
    Malfunction
    Date Received
    October 26, 2016
    Date of Event
    June 16, 2016
    Report Date
    October 10, 2016
    Manufacturer
    CAREFUSION 2200, INC.
    Product Code
    BSY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHEN THE NEEDLE WAS REMOVED FROM THE 8 FR CATHETER, THE BLACK END CAP BROKE OFF AND CAME OUT WITH THE NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    709103 SAFE-T PLUS THORA-PARA CATHETER DRAINAGE TRAY WITH 8 FR CATHETER NEEDLE, CATHETER BSY CAREFUSION 2200, INC. 8F 0000907137

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR UNKNOWN.