BEUDAMED
    FDA Adverse Event Summary report: N

    CENTERMARK PERIPHERALLY INSERTED CENTRAL CATHETER

    MDR report key: 36811 · Received August 30, 1996

    Report

    Report Number
    36811
    Date Received
    August 30, 1996
    Report Date
    August 2, 1996
    Manufacturer
    MENLO CARE, INC.
    Product Code
    DQO
    Report Source
    User Facility report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IMMEDIATELY AFTER INSERTION OF DEVICE INTO THE LEFT CEPHALIC VEIN AND FLUSHING WITH SALINE, THE PT COMPLAINED OF TINGLING, ITCHING, NAUSEA AND BURNING ALL OVER. PT BECAME DIAPHORETIC, PULSE WEAKENED THEN BECAME ABSENT. DEVICE WAS REMOVED AND BENADRYL ADMINISTERED. PT LOST CONSCIOUSNESS AND BECAME APNEIC. CODE (RESPIRATORY ARREST) CALLED. PT GIVEN CPR AND AWOKE SPONTANEOUSLY. PT WAS TRANSFERRED TO MICU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CENTERMARK PERIPHERALLY INSERTED CENTRAL CATHETER PERIPHERALLY INSERTED CENTRAL CATHETER DQO MENLO CARE, INC. UNK 60605

    Patients

    Seq Age Sex Outcome Treatment
    1 *