BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOCONNECT ORAL / ENTERAL SYRINGE

    MDR report key: 7120463 · Received December 15, 2017

    Report

    Report Number
    7120463
    Event Type
    Malfunction
    Date Received
    December 15, 2017
    Date of Event
    November 15, 2017
    Report Date
    December 12, 2017
    Manufacturer
    NEOMED, INC.
    Product Code
    PNR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    NURSE RECEIVED 35 ML ENTERAL FEEDING SYRINGE FROM THE INFANT FORMULA ROOM. RN FOUND SEALING CAP DIFFICULT TO REMOVE. WHILE TRYING TO TWIST CAP FROM SYRINGE BARREL, THE SYRINGE CONNECTOR SNAPPED OFF OF THE SYRINGE BARREL. THE NURSE TRANSFERRED THE BREAST MILK TO ANOTHER SYRINGE AND PROCEEDED WITH THE FEEDING. DAMAGED SYRINGE REMOVED AND SENT TO BIOMEDICAL FOR EVALUATION. MANUFACTURER RESPONSE FOR ENTERAL SYRINGE, ENFIT COMPLIANT, NEOCONNECT (PER SITE REPORTER): AWAITING RESPONSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    899711 NEOCONNECT ORAL / ENTERAL SYRINGE ENTERAL SYRINGES WITH ENTERAL SPECIFIC CONNECTORS PNR NEOMED, INC. NM-S35NC

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR