BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD ACCESS SYSTEMS, INC.

    MDR report key: 3122007 · Received May 15, 2013

    Report

    Report Number
    MW5030228
    Event Type
    Malfunction
    Date Received
    May 15, 2013
    Date of Event
    February 11, 2013
    Report Date
    May 6, 2013
    Product Code
    LJS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT HAD A CENTRAL LINE TRIFUSION CATHETER PLACED ON (B)(6) 2013. THE CATHETER'S CLAMPS BROKE REQUIRING THE CATHETER TO BE REPLACED ON (B)(6) 2013. THIS IS NOT THE FIRST TIME THE PT HAS HAD TO HAVE HIS CATHETER EXCHANGED DUE TO BROKEN CLAMPS. LOT NUMBER IS CURRENTLY UNAVAILABLE. SEVERAL SIMILAR CASES HAVE BEEN SUBMITTED TO THE FDA VIA THE MAUDE FORM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214663 BARD ACCESS SYSTEMS, INC. HICKMAN, TRIFUSION LJS

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR