BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEARLINK/INTERLINK/DUO-VENT

    MDR report key: 8539313 · Received April 23, 2019

    Report

    Report Number
    8539313
    Event Type
    Malfunction
    Date Received
    April 23, 2019
    Date of Event
    March 28, 2019
    Report Date
    April 9, 2019
    Manufacturer
    BAXTER INTERNATIONAL, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    NEW BOTTLE OF NTG NEEDED TO BE HUNG. RN CHANGED PRIMARY TUBING. FIFTEEN MINUTES LATER, RN CALLED INTO ROOM. RN NOTICED LIQUID DRIPPING FROM LUER LOCK ONTO FLOOR. CRACK IDENTIFIED IN LUER LOCK. NTG AND HEPARIN Y-SITE CONNECTED. IV TUBING CHANGED. PUDDLE CLEANED TO PREVENT PATIENT FALL. ACM NOTIFIED OF FAULTY TUBING. ANTIXA ORDERED FOR 9PM TO FOLLOW HEPARIN LEVEL. PA AWARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333741 CLEARLINK/INTERLINK/DUO-VENT SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER INTERNATIONAL, INC. 2C8541S 10R19A16102

    Patients

    Seq Age Sex Outcome Treatment
    1 28105 DA