BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIODYNAMICS BIOFLO PICC

    MDR report key: 6053515 · Received October 20, 2016

    Report

    Report Number
    MW5065557
    Event Type
    Injury
    Date Received
    October 20, 2016
    Date of Event
    October 13, 2016
    Report Date
    October 20, 2016
    Manufacturer
    NAVILYST MEDICAL INC.
    Product Code
    LJS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE PT PRESENTED TO THE ED FOR EVAL OF A POTENTIALLY CLOTTED PICC. A DETERMINATION WAS MADE THAT A NEW DEVICE WOULD NEED TO BE PLACED. THE PICC ACCESS RN WAS CALLED FOR PLACEMENT. UPON REVIEW OF THE POST-INSERTION CHEST X-RAY, THE ED PHYSICIAN NOTED CONCERN FOR RETAINED GUIDEWIRE. RADIOLOGY SHARED THE SAME CONCERN AND F/U IMAGING CONFIRMED THE PRESENCE OF THE FOREIGN BODY. CV SURGERY WAS CONSULTED FOR EVAL AND THE PT WAS ADMITTED TO THE HOSPITAL. SURGICAL INTERVENTION WAS PERFORMED THE FOLLOWING MORNING, AND THE GUIDEWIRE WAS SUCCESSFULLY REMOVED PERCUTANEOUSLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695537 ANGIODYNAMICS BIOFLO PICC ANGIODYNAMICS BIOFLO PICC LJS NAVILYST MEDICAL INC. 4888118

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R