BEUDAMED
    FDA Adverse Event Other Summary report: N

    BALLOON SLG 14 FR X 1.2 CM 1CT/EA

    MDR report key: 3913938 · Received June 6, 2014

    Report

    Report Number
    9612030-2014-00032
    Event Type
    Other
    Date Received
    June 6, 2014
    Report Date
    May 21, 2014
    Manufacturer
    COVIDIEN
    Product Code
    KNT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION IS CURRENTLY UNDERWAY, UPON COMPLETION THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(4) 2014 THAT A CUSTOMER HAD AN ISSUE WITH A FEEDING TUBE. THE CUSTOMER STATES THAT THE BUTTON MALFUNCTIONED ON THE STEM ON THE TUBE. THE CUSTOMER WAS FEEDING THE PATIENT WHEN THEY NOTICED A LOT OF THE FORMULA WAS COMING BACK OUT THROUGH THE STOMA. THE CUSTOMER PULLED THIS BUTTON AND PUT A NEW ONE IN. THE CUSTOMER STATES THE STEM SEPARATED HALF WAY FROM WHERE THE STEM JOINS THE BOTTOM OF THE BUTTON. THE BUTTON WAS IN USE FOR ABOUT 4 MONTHS. THERE WAS NO HARM TO THE PATIENT AS A RESULT. THE CUSTOMER SWITCHED OUT THE BUTTONS. NO MEDICAL INTERVENTION WAS REQUIRED. THE CUSTOMER STATED THAT THEY DEFLATED THE BALLOON AND THEN REMOVED THE BALLOON. IT WAS NOT UNTIL AFTER THEY REMOVED THE BALLOON, THEY REALIZED WHY IT WAS LEAKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331410 BALLOON SLG 14 FR X 1.2 CM 1CT/EA FEEDING TUBE KNT COVIDIEN 714120 A1034439

    Patients

    Seq Age Sex Outcome Treatment
    1 34 MO Other