BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LANGSTON DUAL LUMEN CATHETER

    MDR report key: 4163491 · Received October 10, 2014

    Report

    Report Number
    2134812-2014-00040
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    June 4, 2014
    Report Date
    June 13, 2014
    Manufacturer
    VASCULAR SOLUTIONS, INC.
    Product Code
    DQO
    PMA / PMN Number
    K061565
    Removal / Correction Number
    2134812-05/23/2014-01R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    A LANGSTON DUAL LUMEN CATHETER WAS USED DURING A PATIENT PROCEDURE. UPON COMPLETION OF THE PROCEDURE, THE INNER CATHETER OF THE LANGSTON SEPARATED FROM THE OUTER CATHETER. THE SEPARATED CATHETER WAS RETRIEVED BY HAND. NO PATIENT IMPACT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    640520 LANGSTON DUAL LUMEN CATHETER CATHETER DQO VASCULAR SOLUTIONS, INC. 5540 570929

    Patients

    Seq Age Sex Outcome Treatment
    1