BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIONIX BLUE 14-16 FRENCH

    MDR report key: 4192846 · Received October 16, 2014

    Report

    Report Number
    MW5038703
    Event Type
    Injury
    Date Received
    October 16, 2014
    Date of Event
    October 6, 2014
    Report Date
    October 16, 2014
    Manufacturer
    BIONIX
    Product Code
    KNT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE DECLOGGER WAS USED WITH A CLOGGED J TUBE AFTER FLUID ATTEMPTS WERE UNSUCCESSFUL. APPROX 5 INCHES OF THE DECLOGGER BROKE OFF IN THE J TUBE. PT DID NOT SUFFER ANY ILL EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    657033 BIONIX BLUE 14-16 FRENCH ENTERNAL FEEDING TUBE DECLOGGER KNT BIONIX 911

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention