BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KENDALL

    MDR report key: 2218904 · Received August 16, 2011

    Report

    Report Number
    MW5021793
    Event Type
    Malfunction
    Date Received
    August 16, 2011
    Date of Event
    August 16, 2011
    Report Date
    August 16, 2011
    Manufacturer
    KENDALL
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NE, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    RN DRAWING UP MEDICATION FOR PT USING THE KENDALL MONOJECT SMARTTIP NEEDLELESS MED PREP CANNULA AND SEES A SMALL GRAY METAL SHARD IN THE FLUID. THE LOT NUMBERS WE ARE CURRENTLY USING ARE 101807, 118522, 114422, 108770. PRODUCTS BEING REMOVED FROM USE AT THIS TIME AND AN ALTERNATE PRODUCT BEING OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KENDALL MONOJECT SMARTTIP NEEDLELESS MED PREP CANNULA FMF KENDALL 101807, 118522, 114422

    Patients

    Seq Age Sex Outcome Treatment
    1