BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVASOURCE RENAL

    MDR report key: 12540567 · Received September 27, 2021

    Report

    Report Number
    MW5104241
    Event Type
    Malfunction
    Date Received
    September 27, 2021
    Date of Event
    September 23, 2021
    Report Date
    September 24, 2021
    Manufacturer
    NESTLE HEALTHCARE NUTRITION, INC.
    Product Code
    PIF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THREE OUT OF FOUR BAGS OF NOVASOURCE RENAL WERE BROKEN AT THE CONNECTION SITE WHEN ACCESSED. THE SPIKERIGHT PLUS SITE DETACHES FROM THE BAG. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1435784 NOVASOURCE RENAL GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS PIF NESTLE HEALTHCARE NUTRITION, INC.
    1435785 NOVASOURCE RENAL GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS PIF NESTLE HEALTHCARE NUTRITION, INC.
    1435786 NOVASOURCE RENAL GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS PIF NESTLE HEALTHCARE NUTRITION, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1