BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLOG ZAPPER ENTERAL FEEDING TUBE DECLOGGING SYSTEM

    MDR report key: 9627207 · Received January 24, 2020

    Report

    Report Number
    9627207
    Event Type
    Malfunction
    Date Received
    January 24, 2020
    Date of Event
    January 1, 2020
    Report Date
    January 3, 2020
    Manufacturer
    CORPAK MEDSYSTEMS, INC.
    Product Code
    KNT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD A CLOGGED PEG FEEDING TUBE, CLOG ZAPPER ENTERAL FEEDING TUBE DECLOGGING SYSTEM OBTAINED TO ATTEMPT TO DECLOG THE NG TUBE. INSTRUCTIONS FOLLOWED BY RN TO INSTILL DECLOTTING LIQUID WITH APPLICATOR AND PLASTIC TUBE. WHEN PLASTIC TUBE REMOVED IT BROKE LEAVING 6 INCHES OF PLASTIC TUBING. PATIENT WENT TO IR TO HAVE PEG TUBE REMOVED AND REPLACED, PLASTIC TUBING COULD NOT BE LOCATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88974 CLOG ZAPPER ENTERAL FEEDING TUBE DECLOGGING SYSTEM TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT CORPAK MEDSYSTEMS, INC. 20-0002 0008034165

    Patients

    Seq Age Sex Outcome Treatment
    1 29200 DA Other