BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KANGAROO

    MDR report key: 6771106 · Received August 7, 2017

    Report

    Report Number
    9612030-2017-05140
    Event Type
    Injury
    Date Received
    August 7, 2017
    Date of Event
    August 1, 2017
    Report Date
    December 12, 2017
    Manufacturer
    COVIDIEN
    Product Code
    KNT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE DECONTAMINATED SAMPLE WAS RECEIVED FOR EVALUATION. ACCORDING TO THE CUSTOMER, "THE ACTUAL TUBE WAS DISCARDED AND NOT EXAMINED"; THE SAMPLE INVOLVED IN THE INCIDENT WAS NOT RETURNED FOR EVALUATION; HOWEVER, THE SAMPLE RECEIVED WAS INSPECTED PER PROCEDURE AND THE REPORTED ISSUE WAS NOT CONFIRMED TO BE RELATED TO ANY ISSUE WITH THE DEVICE. THE DEVICE HISTORY RECORD FILE WAS REVIEWED INDICATING THAT PRODUCT WAS RELEASED MEETING ALL QUALITY STANDARD REQUIREMENTS. UPON EXAMINATION OF THE DESCRIPTION OF THE EVENTS THE MOST LIKELY ROOT CAUSE FOR THE BLOOD ON THE NASOGASTRIC TUBE IS IMPROPER INSERTION OF THE TUBE INTO THE PATIENT. IF THE NASOGASTRIC TUBE IS IMPROPERLY INSERTED AND ENTERS THE PATIENTS LUNGS THERE IS A RISK OF INFECTION IF FEEDING FORMULA IS INSERTED INTO THE LUNGS. THIS COMPLAINT WILL BE USED FOR TRACKING AND TRENDING PURPOSES. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT THE PATIENT, A BABY, HAD A NASOGASTRIC TUBE PLACED AT 1700 ON (B)(6)2017. THE RN CHECKED PLACEMENT WITH AN AIR BOLUS WITH EACH FEED AND CARE TIME PER UNIT ROUTINE. THE BABY WAS FED 4ML AT 2300, 0200, 0500. AT ABOUT 0600, THE RN NOTICED BLOOD IN THE FEEDING TUBE. THE RN ASPIRATED THE CONTENTS AND GOT OUT ABOUT 2ML OF BLOOD TINGED FORMULA. THE RN NOTIFIED THE CHARGE RN AND THEY CALLED NNP TO REPORT ISSUE. NNP ORDERED A CHEST X-RAY. THE NG TUBE APPEARED TO BE BEYOND THE RIGHT LUNG IN THE AREA OF THE LIVER. THE NG TUBE WAS REMOVED. NNP ORDERED A NEW TUBE TO BE REPLACED AND TO HOLD ONCE FEEDING AND LAB WORK WAS EVALUATED. AT 0800, A NEW NG TUBE WAS PLACED AND X-RAY CONFIRMED PLACEMENT IN THE STOMACH. THE LUNG CONSOLIDATION WAS CONSISTENT WITH PNEUMONIA SEEN IN RIGHT LUNG ON X-RAY AND LAB CHANGES INDICATE INFLAMMATION AND POSSIBLE INFECTION PER MD. MD TO TREAT WITH 7 DAYS OF ANTIBIOTICS. THE PATIENT REMAINS ON LOW LEVEL RESPIRATORY SUPPORT OF A NASAL CANNULA BEFORE AND AFTER EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    550893 KANGAROO TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT COVIDIEN 461420 1712922564

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention