BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4 FR SINGLE LUMEN GROSHONG NXT CLEARVUE BASIC KI

    MDR report key: 2470449 · Received February 24, 2012

    Report

    Report Number
    3006260740-2012-00054
    Event Type
    Injury
    Date Received
    February 24, 2012
    Date of Event
    January 19, 2012
    Report Date
    February 1, 2012
    Manufacturer
    C. R. BARD INC. (BASD)
    Product Code
    LJS
    PMA / PMN Number
    K034020
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR HAS RECEIVED THE SAMPLE AND WILL BE EVALUATED. RESULTS ARE EXPECTED SOON.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT HAD BEEN RECEIVING MODIFIED DE GRAMONT CHEMOTHERAPY WHICH INCLUDES OXALIPLATIN VIS PICC SINCE (B)(6) 2011. APPROX 200 ML OF OXALIPLATIN LEAKED FROM PIN HOLE IN THE CATHETER AT 5 CM INTO THE PERIPHERAL VESSEL. PT UNDERWENT A WASH OUT WITH NO FURTHER TREATMENT NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 4 FR SINGLE LUMEN GROSHONG NXT CLEARVUE BASIC KI LJS C. R. BARD INC. (BASD) REVD0202

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention