BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

    MDR report key: 5871391 · Received August 12, 2016

    Report

    Report Number
    5871391
    Event Type
    Malfunction
    Date Received
    August 12, 2016
    Date of Event
    June 27, 2016
    Report Date
    July 20, 2016
    Manufacturer
    SMITHS MEDICAL ASI, INC.
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    RN FOUND LARGE AMOUNT OF BLOOD AND IVF ON THE LINEN, CLOTHING, AND UNDER THE IVC DRESSING. THE RN DOCUMENTED THAT SHE ONLY FOUND THE HUB OF THE CATHETER LAYING ON TOP OF THE SKIN. ULTRASOUND OF UPPER LEFT EXTREMITY CONFIRMED CATHETER RETAINED IN CEPHALIC VEIN. SURGERY WAS PERFORMED TO ATTEMPT TO REMOVE THE RETAINED CATHETER, HOWEVER, REMOVAL WAS UNSUCCESSFUL. THE AMOUNT OF BLOOD LOSS BECAUSE OF THIS CATHETER WAS NOT SIGNIFICANT ENOUGH TO REQUIRE A TRANSFUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    524558 CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS FOZ SMITHS MEDICAL ASI, INC. ST3193988

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR