BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TYCO/HEALTHCARE

    MDR report key: 2604836 · Received June 5, 2012

    Report

    Report Number
    MW5025687
    Event Type
    Malfunction
    Date Received
    June 5, 2012
    Date of Event
    May 25, 2012
    Report Date
    June 4, 2012
    Manufacturer
    TYCO HEALTHCARE GROUP, LP
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DEBRIS NOTICED INSIDE SYRINGE AFTER MEDICATIONS WAS ADMINISTERED TO PT -CULTURE TESTED/NEGATIVE. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TYCO/HEALTHCARE KENDALL MONOJECT LUER LOCK SYRINGE FMF TYCO HEALTHCARE GROUP, LP

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR