BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER LOK

    MDR report key: 4252767 · Received November 7, 2014

    Report

    Report Number
    4252767
    Event Type
    Malfunction
    Date Received
    November 7, 2014
    Date of Event
    July 28, 2014
    Report Date
    November 7, 2014
    Manufacturer
    BECTON DICKINSON & CO.
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    LIQUID WAS DISCOVERED ON THE FLOOR BELOW THE IV PUMP AREA IN THE PATIENT'S ROOM. NICARDIPINE SYRINGE WAS INFUSING, WITH THE MEDICATION DRIPPING OFF THE SYRINGE PUMP. THE SYRINGE WAS NOT PROPERLY ADHERED TO THE IV TUBING, THE HUB OF THE SYRINGE WAS FOUND BROKEN, EMBEDDED IN THE IV LINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    719432 BD LUER LOK SYRINGE, PISTON FMF BECTON DICKINSON & CO. 60 ML UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR