BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LANDMARK MIDLINE CATHETER

    MDR report key: 36424 · Received September 3, 1996

    Report

    Report Number
    MW1009842
    Event Type
    Injury
    Date Received
    September 3, 1996
    Date of Event
    August 30, 1996
    Report Date
    September 3, 1996
    Manufacturer
    MENLO CARE, INC.
    Product Code
    FOZ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A 22 GAUGE CATHETER WAS SUCCESSFULLY INSERTED BY THE RN. ON THE SECOND ATTEMPT THE PT COMPLAINED OF FEELING WARM. HE BECAME DIAPHORETIC AND PALE. THE RN INSTRUCTED THE PT TO LOWER HIS HEAD. THE PT LOST CONSCIOUSNESS AND THE RN PLACED HIM ON THE FLOOR TO MAINTAIN AN OPEN AIRWAY. STAFF CALLED 911 AND RN REMAINED WITH THE PT. THE RN CHECKED THE PT'S PULSE AND RESPIRATIONS AND THEY WERE NOT PRESENT. RN REMOVED THE CATHETER WHEN PT LOST CONSCIOUSNESS AND PROCEEDED TO INITIATE CPR PROTOCOL. PT SELF REVIVED AS THE RN BEGAN CPR. THE PT WAS RESPONDING APPROPRIATELY UP UNTIL HE WAS TRANSPORTED TO THE HOSP BY THE AMBULANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LANDMARK MIDLINE CATHETER MIDLINE CATHETER FOZ MENLO CARE, INC. * G05272M

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Life Threatening