BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVAMAX

    MDR report key: 3847223 · Received May 1, 2014

    Report

    Report Number
    3847223
    Event Type
    Malfunction
    Date Received
    May 1, 2014
    Date of Event
    May 1, 2014
    Report Date
    May 1, 2014
    Manufacturer
    CAREFUSION 2200, INC.
    Product Code
    NDN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN NOTICED THAT BONE CEMENT INTERNAL STYLET WAS TOO LOOSE. UPON CLOSER INSPECTION, IT APPEARED THE OUTER NEEDLE WAS THE INCORRECT SIZE PACKAGED BY COMPANY. NEEDLE WAS REPLACED BY ANOTHER CORRECTLY PACKAGED ASSEMBLY. THE PATIENT WAS NOT HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262322 AVAMAX BONE CEMENT HANDLE/STYLET KIT NDN CAREFUSION 2200, INC. * 0000636740

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR