BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5FX60CM SNGL PRO LINE CT

    MDR report key: 4092638 · Received August 19, 2014

    Report

    Report Number
    2518902-2014-00054
    Event Type
    Malfunction
    Date Received
    August 19, 2014
    Date of Event
    July 18, 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 CRACKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    496933 5FX60CM SNGL PRO LINE CT CENTRAL VENOUS CATHETER LJS MEDCOMP MR28035101 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Required Intervention