BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEOCONNECT

    MDR report key: 8063599 · Received November 13, 2018

    Report

    Report Number
    8063599
    Event Type
    Injury
    Date Received
    November 13, 2018
    Date of Event
    November 8, 2018
    Report Date
    November 8, 2018
    Manufacturer
    NEOMED, INC
    Product Code
    PNR
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A NEOCONNECT ORAL ENTERAL SYRINGE WITH ENFIT CONNECTOR WAS OBTAINED IN ORDER TO DELIVER ORAL/ENTERAL MEDICATION TO AN INFANT. IT WAS NOTED WHEN THE PACKAGING WAS OPENED THAT IT WAS NOT AN ENFIT CONNECTOR THAT WAS IN THE PACKAGE. IT WAS A STRAIGHT TIP CONNECTOR. ANOTHER SYRINGE WAS OBTAINED AND IT HAD AN ENFIT TIP. THE PACKAGING OF BOTH OF THESE SYRINGES HAD THE EXACT SAME REFERENCE AND LOT NUMBERS AND WERE LABELED THE SAME. THE STRAIGHT TIP CONNECTOR IS NOT ONE THAT WE USE IN OUR FACILITY BECAUSE IT CAN INADVERTENTLY BE CONNECTED TO AN IV CATHETER AND INCREASE THE POTENTIAL OF AN ORAL MEDICATION/FEED BEING ENTERED INTO AN IV. FORTUNATELY, THIS DID NOT REACH THE PATIENT AND THE NURSE STOPPED WHEN SHE NOTICED THE CATHETER TIP WAS NOT COMPATIBLE WITH THE ENFIT SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    905953 NEOCONNECT SYRINGE, ENTERAL PNR NEOMED, INC PNM-S12NC 20171110

    Patients

    Seq Age Sex Outcome Treatment
    1 14 DA