BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDCOMP 0.18

    MDR report key: 3121789 · Received May 14, 2013

    Report

    Report Number
    MW5030204
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Date of Event
    May 10, 2013
    Report Date
    May 14, 2013
    Manufacturer
    MEDICAL COMPONENTS, INC.
    Product Code
    LJS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    DURING ATTEMPTED PICC LINE INSERTION WHEREIN DEVICE WAS USED, IT WAS NOTED THAT THE GUIDEWIRE COULD NOT BE ADVANCED AFTER 6-8 CM. WHEN THIS WAS PULLED BACK, IT WAS NOTED BY THE PICC RN THAT A 5CM PIECE HAD BROKEN OFF AND LEFT IN PT'S RIGHT ARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212230 MEDCOMP 0.18 PICC LINE LJS MEDICAL COMPONENTS, INC. REF G65S MBHW4

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Other