BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD ACCESS SYSTEM

    MDR report key: 3759674 · Received April 15, 2014

    Report

    Report Number
    MW5035695
    Event Type
    Injury
    Date Received
    April 15, 2014
    Date of Event
    March 20, 2014
    Report Date
    April 3, 2014
    Manufacturer
    BARD ACCESS SUSTEM
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    POLYURETHANE FRAGMENT OF CATHETER BROKE LOOSE AND LODGED IN SOFT TISSUE OF THE LEFT INNER HUMERUS REQUIRING SURGICAL REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    229338 BARD ACCESS SYSTEM POWERGLIDE MIDLINE CATHETER FOZ BARD ACCESS SUSTEM M120100 REX0857

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention