BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6FX60CM DUAL PRO LINE CT

    MDR report key: 4092639 · Received August 19, 2014

    Report

    Report Number
    2518902-2014-00055
    Event Type
    Malfunction
    Date Received
    August 19, 2014
    Date of Event
    August 6, 2014
    Report Date
    August 19, 2014
    Manufacturer
    MEDCOMP
    Product Code
    LJS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION HAS BEEN INITIATED. WHEN THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    LINE IS BROKEN NEAR PURPLE HUB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    496790 6FX60CM DUAL PRO LINE CT CENTRAL VENOUS CATHETER LJS MEDCOMP MR28036201 MFWF240

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Required Intervention