BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD ACCESS SYSTEM

    MDR report key: 513956 · Received February 19, 2004

    Report

    Report Number
    MW1031266
    Event Type
    Malfunction
    Date Received
    February 19, 2004
    Date of Event
    February 19, 2004
    Report Date
    February 19, 2004
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NM, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT'S PORT ACCESSED WITH HUBER NEEDLE Z-16 AT CLINIC. TUBING BETWEEN HUBER NEEDLE AND LOCK BROKE INTO 2 PIECES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD ACCESS SYSTEM WINGED INFUSION SET - 22G 3/4" FMI BARD ACCESS SYSTEMS 2205222 22KNX181

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR Other NEEDLE PRODUCT CODE MS426221.| PORT REACCESSED USING MED STREAM NON-CORING