BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD ACCESS SYSTEMS

    MDR report key: 1652472 · Received April 1, 2010

    Report

    Report Number
    MW5015441
    Event Type
    Injury
    Date Received
    April 1, 2010
    Date of Event
    March 29, 2010
    Report Date
    April 1, 2010
    Manufacturer
    BARD
    Product Code
    LFJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OK, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT WITH EXTRAVASATION OF CHEMO AGENT CYTOXAN INFUSING THROUGH LEFT SIDE QUINTON CATHETER. PT HAD COMPLAINT OF CHEST PRESSURE AND SHORTNESS OF BREATH WITH EVIDENT EDEMA TO INSERTIONS SITE OF QUINTON CATHETER. PT WAS TAKEN TO RADIOLOGY FLUOROSCOPY WHERE QUINTON WAS CATHETER CHECKED FOR FLOW USING CONTRAST WHICH REVEALED EXTRAVASATION OF CONTRAST INTO SUPRACLAVICULAR SOFT TISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD ACCESS SYSTEMS QUINTON CATHETER HEMOSPLIT 19CM DIAL LFJ BARD RESL0788

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization CHEMO THERAPY