BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOJECT

    MDR report key: 18300557 · Received December 11, 2023

    Report

    Report Number
    18300557
    Event Type
    Malfunction
    Date Received
    December 11, 2023
    Date of Event
    October 5, 2023
    Report Date
    October 6, 2023
    Manufacturer
    CARDINAL HEALTH, INC.
    Product Code
    PNR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    WE HAVE IDENTIFIED THAT THE CARDINALHEALTH MONOJECT 60ML ENTERAL SYRINGES (REF 460SE; LOT 230501) ARE NOT IDENTIFIED AS MONOJECT SYRINGES IN OUR FEEDING PUMPS AND THEREFORE CANNOT DELIVER FEEDS TO BABIES. THIS IS CURRENTLY THE ONLY LOT NUMBER AVAILABLE TO US TO TEST, BUT 100% OF THOSE TESTED HAVE FAILED USING MULTIPLE PUMPS AND PUMP SETTINGS. WE HAVE NOT EXPERIENCED ANY ISSUES WITH THE MONOJECT SYRINGES PACKAGED AS COVIDIEN MONOJECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1884527 MONOJECT ENTERAL SYRINGES WITH ENTERAL SPECIFIC CONNECTORS PNR CARDINAL HEALTH, INC. 460SE 230501

    Patients

    Seq Age Sex Outcome Treatment
    1 28 DA Female