BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW - CENTRAL LINE INSERTION KIT

    MDR report key: 3020726 · Received March 18, 2013

    Report

    Report Number
    MW5029443
    Event Type
    Malfunction
    Date Received
    March 18, 2013
    Date of Event
    March 10, 2013
    Report Date
    March 18, 2013
    Manufacturer
    TELEFLEX
    Product Code
    DQO
    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 ATTEMPTING TO SUTURE FEMORAL LINE IN PT. 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
    111947 ARROW - CENTRAL LINE INSERTION KIT CENTRAL LINE INSERTION KIT W/HEMOSTAT DQO TELEFLEX RF2122201

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR