BEUDAMED
    FDA Adverse Event Other Summary report: N

    BARD ACCESS SYSTEM

    MDR report key: 109207 · Received July 22, 1997

    Report

    Report Number
    MW4001899
    Event Type
    Other
    Date Received
    July 22, 1997
    Date of Event
    June 25, 1997
    Report Date
    July 7, 1997
    Manufacturer
    BARD ACCESS SYSTEMS/FIELD ASU.
    Product Code
    DQO
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    BROVIAC CATHETER INSERTED ON 6/18/97 IN THE OR BY DR. CATHETER SITE BECAME REDDENED AND LINE BECAME SLUGGISH WITH LEAKING. ON 6/25/97, BROVIAC REMOVED AND CRACKED NOTED, NEW BROVIAC INSERTED. ON 6/26/97, THE SECOND CATHETER WAS NOTED TO BE LEAKING WITH INFUSION. DR REMOVED THE CATHETER AND IT WAS NOTED THE CRACK WAS IN THE SAME LOCATION BELOW THE JUNCTION OF THE SHEATH AS BROVIAC #1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD ACCESS SYSTEM Implant BROVIAC SINGLE LUMEN CATHETER DQO BARD ACCESS SYSTEMS/FIELD ASU. * 6/18/97 36KG8342

    Patients

    Seq Age Sex Outcome Treatment
    1 2 MO Other