BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LANDMARK MIDLINE CATHETER

    MDR report key: 35203 · Received July 24, 1996

    Report

    Report Number
    35203
    Event Type
    Injury
    Date Received
    July 24, 1996
    Date of Event
    May 17, 1996
    Report Date
    June 4, 1996
    Manufacturer
    MENLO CARE, INC.
    Product Code
    FOZ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT WAS PREPPED WITH BETADINE AND ALCOHOL FOR CATHETER PLACEMENT. PT WAS ANXIOUS AND WAS ON LATEX PRECAUTIONS BUT HAD NO HISTORY OF ADVERSE REACTIONS. UPON VENIPUNCTURE, BLOOD RETURNED. CATHETER WAS ADVANCED OVER 2-3 MINS WITH FLUSHING. SHORTLY AFTER COMPLETION, PT COMPLAINED OF PRESSURE IN HIS HEAD. NOTED FLUSHED FACE. PT PLACED ON BLOW-BY O2 - NOTED FLUSHING ON CHEST AND UPPER EXTREMITIES. BENADRYL GIVEN IV. BP NOTED 73/30. IV FLUID BOLUS GIVEN. BP RETURNED WITHIN 10 MINS TO PRE-PROCEDURE 120/60. PT SYMPTOMS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LANDMARK MIDLINE CATHETER CATHETER FOZ MENLO CARE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Required Intervention