BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPLANTED CATHETER

    MDR report key: 3162466 · Received June 6, 2013

    Report

    Report Number
    3006260740-2013-00286
    Event Type
    Malfunction
    Date Received
    June 6, 2013
    Report Date
    May 21, 2013
    Manufacturer
    C. R. BARD INC. (BASD)
    Product Code
    LJS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER, AT THIS TIME, FOR EVALUATION. A LOT HISTORY REVIEW (LHR) REVIEW IS NOT POSSIBLE, AS NO MANUFACTURING LOT NUMBER HAS BEEN PROVIDED BY THE COMPLAINANT.

    Description of Event or Problem · 1

    PULLING GUIDEWIRE BACK AND IT FRAYED. CONFIRMED WITH ULTRASOUND THAT NONE WAS LEFT IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251508 IMPLANTED CATHETER PERCUTANEOUS IMPLANTED LONG TERM LJS C. R. BARD INC. (BASD) UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention