BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIDLINE

    MDR report key: 8286312 · Received January 28, 2019

    Report

    Report Number
    MW5083436
    Event Type
    Malfunction
    Date Received
    January 28, 2019
    Date of Event
    December 22, 2018
    Report Date
    January 25, 2019
    Manufacturer
    ACCESS SCIENTIFIC, LLC
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD MIDLINE CATHETER IN PLACE (PW, 4FR). DURING CPR IT WAS NOTED THE TAN BELL -SHAPED PIECE THAT COVERS THE WHITE HUB WITH THE LINE MARKINGS HAD SEPARATED (CAME LOOSE) AND WAS MIGRATING DOWN THE CATHETER PULLING THE MIDLINE OUT. THE MIDLINE WAS REMOVED AND A CVC WAS PLACED. IT WAS NOTED THE CATHETER WAS KINKED. NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74997 MIDLINE INTRODUCER, CATHETER DYB ACCESS SCIENTIFIC, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR