BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEDIATRIC/INFANT LUMBAR PUNCTURE TRAY

    MDR report key: 3758554 · Received April 4, 2014

    Report

    Report Number
    3758554
    Event Type
    Malfunction
    Date Received
    April 4, 2014
    Date of Event
    January 28, 2014
    Report Date
    April 4, 2014
    Manufacturer
    CAREFUSION 2200, INC.
    Product Code
    OJG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    SD, US

    Narratives

    Description of Event or Problem · 1

    WHEN THE PROVIDER OPENED THE STERILE LUMBAR PUNCTURE TRAY, A LONG DARK HAIR WAS OBSERVED UNDER THE STERILE WRAPPINGS ON TOP OF THE STERILE TROCAR. AS IT WAS NOTED PRIOR TO THE PROCEDURE, NONE OF THE ITEMS WERE REMOVED FROM THE PACKAGING AND THE ENTIRE TRAY WAS TAKEN FROM THE ROOM AND REPLACED WITH A NEW SET UP FOR THE PROCEDURE.======================MANUFACTURER RESPONSE FOR PEDIATRIC/INFANT LUMBAR PUNCTURE TRAY, CAREFUSION PEDIATRIC/INFANT LUMBAR PUNCTURE TRAY (PER SITE REPORTER).======================DIRECTOR MATERIALS MANAGEMENT CONTACTED SALES REP IMMEDIATELY WITH INFORMATION AS HAVE HAD SEVERAL PROBLEMS WITH STERILE TRAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204173 PEDIATRIC/INFANT LUMBAR PUNCTURE TRAY NEUROLOGICAL TRAY OJG CAREFUSION 2200, INC. * 0000556154

    Patients

    Seq Age Sex Outcome Treatment
    1 *