BEUDAMED
    FDA Adverse Event Other Summary report: N

    BARD ACCESS SYSTEMS

    MDR report key: 2132608 · Received June 13, 2011

    Report

    Report Number
    MW5020999
    Event Type
    Other
    Date Received
    June 13, 2011
    Date of Event
    May 17, 2011
    Report Date
    June 13, 2011
    Manufacturer
    BARD ACCESS SYSTEMS, INC.
    Product Code
    LJS
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    NURSE STARTED TO FLUSH A HICKMAN CATHETER. AS SHE WAS FLUSHING IT, SHE HEARD A "POP" NOISE AND NOTICED THAT THE TUBING HAD A DIAGONAL SPLIT IN THE TUBING. THE TUBING WAS CLAMPED AND THE HICKMAN CATHETER HAD TO BE REMOVED. SPECIAL PROCEDURE STAFF DESCRIBED THE TUBING AS LOOKING RIPPED. PT DENIED ANY TRAUMA TO CATHETER. THE PT DID NOT HAVE AN ADVERSE REACTION, PAIN, OR DETERIORATION IN HEALTH DUE TO THE CATHETER TUBING SPLIT. REASON FOR USE: CHEMOTHERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD ACCESS SYSTEMS 9FR DUAL LUMEN HICKMAN CATHETER LJS BARD ACCESS SYSTEMS, INC. HUUL1312

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR