BEUDAMED
    FDA Adverse Event Injury Summary report: N

    9.5 FR D/L CATHETER

    MDR report key: 1140945 · Received August 28, 2008

    Report

    Report Number
    3006260740-2008-00099
    Event Type
    Injury
    Date Received
    August 28, 2008
    Report Date
    August 20, 2008
    Manufacturer
    C. R. BARD INC. (BASD)
    Product Code
    LJS
    PMA / PMN Number
    K061179
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVAL. A CHR REVIEW IS NOT POSSIBLE, AS NO MANUFACTURING LOT NUMBER HAS BEEN PROVIDED BY THE COMPLAINANT.

    Description of Event or Problem · 1

    THE FACILITY HAS NOTICED A SIGNIFICANTLY HIGHER INFECTION RATE AND DVT RATE. THE CATHETER IS PISTONED AND THE CUFF ISN'T SECURING THE CATHETER PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9.5 FR D/L CATHETER LJS C. R. BARD INC. (BASD) UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention