BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW CENTRAL LINE INSERTION KIT

    MDR report key: 3020733 · Received March 18, 2013

    Report

    Report Number
    MW5029446
    Event Type
    Malfunction
    Date Received
    March 18, 2013
    Date of Event
    March 10, 2013
    Report Date
    March 18, 2013
    Manufacturer
    TELEFLEX ARROW
    Product Code
    DQY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    HEMOSTAT IN CENTRAL LINE INSERTION KIT BROKE WHILE MD ONLY ABLE TO INSERT ONE SUTURE IN LINE DUE TO EQUIPMENT FAILURE. NO HARM TO PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    112303 ARROW CENTRAL LINE INSERTION KIT HEMOSTAT DQY TELEFLEX ARROW RF 2122201

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR