BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SET, INTRAVASCULAR, TUBING

    MDR report key: 8887386 · Received August 13, 2019

    Report

    Report Number
    8887386
    Event Type
    Malfunction
    Date Received
    August 13, 2019
    Date of Event
    June 26, 2019
    Report Date
    August 2, 2019
    Manufacturer
    BECTON DICKINSON
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    AFTER ORTHOPEDIC SURGERY, THE PATIENT HAD PCA MORPHINE VIA ALARIS PUMP. DURING THE NIGHT, THE PATIENT'S PAIN INCREASED DESPITE PCA ADMINISTRATION. RN THEN NOTICED THE PCA TUBING WAS WET AND DISCOVERED A CRACK IN THE TUBING. THE TUBING WAS REPLACED AND THEN PAIN BECAME BETTER CONTROLLED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684128 SET, INTRAVASCULAR, TUBING FPA BECTON DICKINSON

    Patients

    Seq Age Sex Outcome Treatment
    1 4745 DA