BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE ENTERAL 60 ML

    MDR report key: 2302009 · Received September 29, 2011

    Report

    Report Number
    2302009
    Event Type
    Malfunction
    Date Received
    September 29, 2011
    Date of Event
    September 12, 2011
    Report Date
    September 29, 2011
    Manufacturer
    NEOMED, INC.
    Product Code
    KNT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN, US

    Narratives

    Description of Event or Problem · 1

    LAST MONTH, THE SYRINGE USED TO ADMINISTER TUBE FEEDINGS IN NEONATES VIA THE MEDFUSION SYRINGE PUMP WAS NOTED TO HAVE A VERY "LOOSE" PLUNGER, WHICH IS ABNORMAL WHEN COMPARED TO OTHER SYRINGES OF THE SAME BRAND. UPON THE OBSERVATION OF THE TUBE FEEDING, THE LIQUID HAD RUN ONTO THE FLOOR UNDER THE INFUSION PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYRINGE ENTERAL 60 ML ENTERAL FEEDING SYRINGE KNT NEOMED, INC. NM-S60EO *

    Patients

    Seq Age Sex Outcome Treatment
    1 *