BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOJECT

    MDR report key: 3099118 · Received May 2, 2013

    Report

    Report Number
    3099118
    Event Type
    Malfunction
    Date Received
    May 2, 2013
    Date of Event
    April 27, 2013
    Report Date
    May 2, 2013
    Manufacturer
    COVIDIEN, FORMERLY KENDALL A DIVISION OF TYCO HEALTHCARE
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE TIP OF THE SYRINGE BROKE OFF INTO THE IV TUBING WHEN ATTEMPTING TO FLUSH THE REMAINDER OF MEDICATION; THUS THE RN WAS UNABLE TO FLUSH REMAINING MEDICATION IN THE TUBING. IV CONTAINED CLINDAMYCIN MEDICATION. DOSAGE WAS 450 MG. A NURSE ADDED THAT THE TIP BROKE OFF FIRMLY INTO THE END OF THE TUBING. NO PATIENT HARM OR INJURY.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191535 MONOJECT SYRINGE, PISTON FMF COVIDIEN, FORMERLY KENDALL A DIVISION OF TYCO HEALTHCARE * 263606

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR