BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KANGAROO

    MDR report key: 17388257 · Received July 25, 2023

    Report

    Report Number
    17388257
    Event Type
    Malfunction
    Date Received
    July 25, 2023
    Date of Event
    May 3, 2023
    Report Date
    June 13, 2023
    Manufacturer
    CARDINAL HEALTH
    Product Code
    KNT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    MALE WAS ADMITTED FOR PLANNED RIGHT PARTIAL GLOSSECTOMY, RIGHT SELECTIVE NECK DISSECTION, TRACHEOSTOMY, LEFT RADIAL FOREARM FREE FLAP, FULL THICKNESS SKIN GRAFT, AND SENTINEL LYMPH NODE BIOPSY. A NASOGASTRIC FEEDING TUBE WAS PLACED DURING THE SURGICAL PROCEDURE. A PLACEMENT CONFIRMATION PORTABLE ABDOMINAL X-RAY WAS ORDERED BY THE SURGEON. THE X-RAY EXAM STARTED AND WAS COMPLETED. THE PACU NURSE GAVE HANDOVER TO THE DIRECT CARE NURSE, INCLUDING ¿X-RAY COMPLETED FOR NGT PLACEMENT. PENDING READ.¿ THE PATIENT WAS TRANSFERRED TO THE UNIT. A FEEDING TUBE ASSESSMENT WAS PLACED BY THE DIRECT CARE NURSE. THE SURGEON WROTE A NURSING COMMUNICATION ORDER ¿OKAY TO USE DOBHOFF FOR TUBE FEEDING/MEDICATION ADMINISTRATION¿. THE FEEDING TUBE WAS FLUSHED, AND MEDS GIVEN. TUBE FEEDING WAS STARTED. DURING THE NIGHT SHIFT NURSE ASSESSMENT AND WHILE FLUSHING THE FEEDING TUBE, THE STYLET WAS FOUND TO STILL BE IN THE FEEDING TUBE. THE TUBE FEEDING WAS PAUSED, THE RAPID RESPONSE NURSE WAS CONSULTED, AND THE SURGEON NOTIFIED. PER THE SURGEON, IT WAS OKAY TO REMOVE THE STYLET AND KEEP USING THE EXISTING FEEDING TUBE. THE FEEDING TUBE WAS REMOVED AND FOUND TO BE A KANGAROO FEEDING TUBE WITH IRIS TECHNOLOGY. MANUFACTURER RESPONSE FOR TUBES, GASTROINTESTINAL (AND ACCESSORIES), KANGAROO (PER SITE REPORTER). DESPITE MULTIPLE SIMILAR EVENTS (NOW 5) AND REPEATED CONVERSATIONS WITH THE MANUFACTURER, THERE HAS BEEN NO FOLLOW-UP ON THE CURRENT DESIGN OF THE IRIS FEEDING TUBE, WHICH DOES NOT HAVE HUMAN FACTORS BASED CHARACTERISTICS FOR CAREGIVERS TO IDENTIFY WHAT IS THE STYLET AND WHAT IS NOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1369058 KANGAROO TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT CARDINAL HEALTH 461243E

    Patients

    Seq Age Sex Outcome Treatment
    1 22630 DA Male