BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM, BRIDLE, FEEDING TUBE, 10 FR, NASAL TUBE,RETAINING

    MDR report key: 2386931 · Received December 5, 2011

    Report

    Report Number
    2386931
    Event Type
    Malfunction
    Date Received
    December 5, 2011
    Date of Event
    October 27, 2011
    Report Date
    November 29, 2011
    Manufacturer
    APPLIED MEDICAL TECHNOLOGY
    Product Code
    KNT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    AT END OF THE CASE, THE RESIDENT WENT TO SECURE A DOBHOFF TUBE WITH THE APPLIED MEDICAL TECHNOLOGY (AMT) BRIDLE. AFTER INSERTING IT INTO THE NOSE, THE TWO MAGNETIC ENDS OF THE DEVICE MET. HE ATTEMPTED TO PULL THE DEVICE AS USUAL, BUT THE END CAME OUT WITH NO MAGNET ATTACHED. IT APPEARED TO HAVE BROKEN OFF COMPLETELY. WE THEN GOT A NASAL LOCAL TRAY SO THE RESIDENT COULD USE A NASAL SPECULUM TO LOOK INTO THE SINUS. THE SMALL MAGNET COULD NOT BE LOCATED SO WE THEN GOT A SINUS SCOPE FOR A BETTER, DEEPER VIEW. THE PIECE COULD STILL NOT BE LOCATED. THEY ARE GOING TO GET A CT OF THE HEAD AND NECK SINCE THE PATIENT WILL BE IN THE HOSPITAL FOR A NUMBER OF DAYS AND DECIDE ON A PLAN ONCE THAT IS COMPLETE. AWAITING RESPONSE FROM MFR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYSTEM, BRIDLE, FEEDING TUBE, 10 FR, NASAL TUBE,RETAINING BRIDLE, FEEDING TUBE 10 FR; NASAL TUBE RETAINING SYSTEM KNT APPLIED MEDICAL TECHNOLOGY * 11082168

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR