BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOJECT

    MDR report key: 7335398 · Received March 13, 2018

    Report

    Report Number
    7335398
    Event Type
    Malfunction
    Date Received
    March 13, 2018
    Date of Event
    January 25, 2018
    Report Date
    February 13, 2018
    Manufacturer
    COVIDIEN LP
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A COVIDEN 12ML MONOJECT SYRINGE HAD A CRACK DOWN THE ENTIRE BARREL OF THE SYRINGE. PHARMACY TECHNICIAN WHILE DRAWING UP CONCENTRATED POTASSIUM CHLORIDE HAD SOLUTION SPRAY ALL OVER HER PERSON. NO INJURY OCCURRED TO TECHNICIAN. THE MEDICATION WAS PREPARED AGAIN AND DISPENSED TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    179517 MONOJECT SYRINGE, PISTON FMF COVIDIEN LP 1181200777 17H02763X

    Patients

    Seq Age Sex Outcome Treatment
    1