BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LANDMARK MIDLINE CATHETER

    MDR report key: 35010 · Received August 5, 1996

    Report

    Report Number
    MW1009645
    Event Type
    Malfunction
    Date Received
    August 5, 1996
    Date of Event
    June 4, 1996
    Report Date
    June 4, 1996
    Manufacturer
    MENLO CARE
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    NURSE IN CLASS TO LEARN IV INSERTIONS OF CATHETER INTO NURSE #1 L ARM. NURSE C/O "FEELING FUNNY" DURING INSERTION AND FLUSH. C/O SORE THROAT, "CLOSING FEELING OF THROAT," HAD LUMP IN R SIDE OF HEAD "ULCER DEVELOPED IN MOUTH," C/O SOB. CATHETER REMOVED, EPINEPHRINE GIVEN AND NURSE SENT TO ER. ALL SX RESOLVED. WAS GIVEN BENADRYL AND SENT HOME. NURSE HAS HX OF LATEX SENSITIVITY, RN INSERTING CATHETER HAD LATEX GLOVES ON, NS USED, FLUSH HAS LATEX SEPTUM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LANDMARK MIDLINE CATHETER MIDLINE CATHETER FOZ MENLO CARE 24G 6" 511271M

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO