BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD

    MDR report key: 2123764 · Received May 31, 2011

    Report

    Report Number
    2123764
    Event Type
    Malfunction
    Date Received
    May 31, 2011
    Date of Event
    April 22, 2009
    Report Date
    April 24, 2009
    Manufacturer
    BARD ACCESS SYSTEMS, INC.
    Product Code
    LJS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    THERE WAS A LOSS OF STRUCTURAL INTEGRITY TO THE BROVIAC'S LINE. UPON DISCOVERY, THE BROVIAC WAS FOUND TO BE BUBBLING, AND UPON FURTHER INVESTIGATION AND REPAIR, THE LINE'S INNER AND OUTER SHEATH'S WAS DISCOVERED TO HAVE BECOME SEPARATED FROM EACH OTHER. BLOOD WAS FOUND TO BE BETWEEN THE INNER AND OUTER SHEATH.NORMALLY, THE TWO PARTS APPEAR AS ONE, HOWEVER, IN THIS CASE, YOU COULD CLEARLY SEE THE TWO PARTS SEPARATED ALL THE WAY UP TO THE PATIENT'S INSERTION SITE (ALL EIGHT INCHES OF AVAILABLE TUBING WAS DEFECTIVE IN THIS WAY).UPON SHARING THIS SUSPECTED FAULTY BROVIAC WITH OTHER STAFF, IT WAS DISCOVERED TO NOT BE AN ISOLATED INCIDENT. FURTHER INVESTIGATIONS REVEAL SEVERAL RECENT DEFECTS (OVER THE LAST 2-3 MONTHS) THAT HAD TO BE REPAIRED, AND THE REPAIRS ALL APPEAR TO BE RELATED TO THE STRUCTURAL INTEGRITY (SEPARATION OF INNER AND OUTER SHEATHS).THOSE WHO DO NOT ROUTINELY REPAIR BROVIAC LINES MAY NOT RECOGNIZE THE DEFECT. MORE EXPERIENCED STAFF DOES NOTICE THIS SEPARATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD CATHETER, PICC LJS BARD ACCESS SYSTEMS, INC. TWO 4.2 FRENCH SINGLE LUMEN BROVIACS, AND 7 FRENCH DOUBLE LUMEN (2 SEPARATE CASE HUSK1802

    Patients

    Seq Age Sex Outcome Treatment
    1 *