BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BROVIAC CATHETER 2.7 SINGLE LUMEN

    MDR report key: 2151684 · Received June 23, 2011

    Report

    Report Number
    2151684
    Event Type
    Malfunction
    Date Received
    June 23, 2011
    Date of Event
    June 10, 2011
    Report Date
    June 21, 2011
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    LJS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PHYSICIAN ORDERED A DRESSING CHANGE AND AN APPLICATION OF MEDICATION TO THE PATIENT'S BROVIAC CATHETER SITE. AS THE NURSE REMOVED THE DRESSING, IT WAS NOTED THAT THE BROVIAC CATHETER WAS BROKE IN HALF. THE CATHETER WAS IMMEDIATELY CLAMPED BY THE NURSE AND THEN DISCONTINUED BY THE PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BROVIAC CATHETER 2.7 SINGLE LUMEN CATHETER, PICC LJS BARD ACCESS SYSTEMS * REVA0630

    Patients

    Seq Age Sex Outcome Treatment
    1 3 WK