BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOJECT SYRINGE

    MDR report key: 283495 · Received June 9, 2000

    Report

    Report Number
    MW4002802
    Event Type
    Malfunction
    Date Received
    June 9, 2000
    Manufacturer
    THE KENDALL CO.
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    NO INFORMATION

    Narratives

    Description of Event or Problem · 1

    THE TIP OF THE MONOJECT SYRINGE BROKE OFF AFTER BEING CONNECTED TO THE EXTENSION SET AND WAS SENT TO THE PT'S HOUSE FOR INFUSION OF VANCOMYCIN 1.25G IN 0.9% OF SODIUM CHLORIDE. THE DEFECT WAS OBSERVED AND REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MONOJECT SYRINGE SYRINGE FMF THE KENDALL CO. NA 369582

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO VANCOMYCIN 1.25 G IN 0.9% NACL