BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    35CC LL SYR.

    MDR report key: 384461 · Received March 21, 2002

    Report

    Report Number
    1650158-2002-00001
    Event Type
    Malfunction
    Date Received
    March 21, 2002
    Date of Event
    January 21, 2002
    Report Date
    March 19, 2002
    Manufacturer
    TYCO/HEALTHCARE/KENDALL
    Product Code
    FMF
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO TYCO/HEALTHCARE/KENDALL VIA MEDWATCH 1023910 ON 03/2002 THAT A MEDICATION ERROR OCCURRED. ON FURTHER INVESTIGATION, IT WAS DISCOVERED THE MEDICATION WAS GIVEN BUT OVER AN EXTENDED TIME PERIOD. NO HARM TO PT. THE SAMPLE WAS DISCARDED AT THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 35CC LL SYR. MONOJECT 35CC SYRINGES FMF TYCO/HEALTHCARE/KENDALL * 136004228, 136004228

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other