BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEVADAPTER

    MDR report key: 4064232 · Received August 29, 2014

    Report

    Report Number
    MW5038055
    Event Type
    Malfunction
    Date Received
    August 29, 2014
    Date of Event
    August 27, 2014
    Report Date
    August 29, 2014
    Manufacturer
    B BRAUN
    Product Code
    LHI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    B BRAUN TEVADAPTOR SYRINGE ADAPTER; DEVICE FAILURE. WHEN DEVICE IS DISENGAGED NEEDLE FAILS TO RETRACT. THIS DEVICE HAS BEEN IN USE AT THIS FACILITY FOR APPROX 6 WEEKS. TEN ADAPTORS HAVE FAILED, 1 RN SUSTAINED A NEEDLE STICK AS A RESULT OF THE DEVICE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    528245 TEVADAPTER SYRINGE ADAPTER LHI B BRAUN 412118 VARIOUS
    528246 TEVADAPTER SYRINGE ADAPTER LHI B BRAUN 412118 VARIOUS
    528247 TEVADAPTER SYRINGE ADAPTER LHI B BRAUN 412118 VARIOUS
    528248 TEVADAPTER SYRINGE ADAPTER LHI B BRAUN 412118 VARIOUS
    528249 TEVADAPTER SYRINGE ADAPTER LHI B BRAUN 412118 VARIOUS
    528250 TEVADAPTER SYRINGE ADAPTER LHI B BRAUN 412118 VARIOUS
    528251 TEVADAPTER SYRINGE ADAPTER LHI B BRAUN 412118 VARIOUS
    528252 TEVADAPTER SYRINGE ADAPTER LHI B BRAUN 412118 VARIOUS
    528253 TEVATAPTER SYRINGE ADAPTER LHI B BRAUN 412118 VARIOUS
    528306 TEVADAPTER SYRINGE ADAPTER LHI B BRAUN 412118 VARIOUS

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR