BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KANGAROO

    MDR report key: 8166206 · Received December 14, 2018

    Report

    Report Number
    9612030-2018-00154
    Event Type
    Malfunction
    Date Received
    December 14, 2018
    Date of Event
    December 7, 2018
    Report Date
    February 6, 2019
    Manufacturer
    COVIDIEN
    Product Code
    KNT
    UDI-DI
    10884521582996
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    117

    Narratives

    Additional Manufacturer Narrative · 0

    THE UNIT WAS TRIAGED AND THE REPORTED ISSUE COULD NOT BE CONFIRMED AT THIS TIME. ALL DEVICE HISTORY RECORDS ARE REVIEWED FOR QUALITY INSPECTIONS AND PARAMETER COMPLIANCE PRIOR TO RELEASING THE PRODUCT FOR SHIPMENT. COMPLAINT TRENDING INFORMATION IS BEING REVIEWED ON A MONTHLY BASIS AND IF A TREND IS OBSERVED, ACTIONS WILL BE TAKEN AS NECESSARY. MEDTRONIC, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS" OR HAS "MALFUNCTIONED". THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE IT BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. 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.

    Additional Manufacturer Narrative · 1

    THE INCIDENT SAMPLE HAS BEEN REQUESTED BUT TO DATE HAS NOT BEEN RECEIVED FOR EVALUATION. IF THE SAMPLE IS RECEIVED, OR IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED A FOLLOW-UP REPORT WILL BE SUBMITTED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT UNDERNEATH THE RIDGE OF THE CONNECTOR ATTACHED TO THE FEEDING TUBE THE PLASTIC HAS CRACKED. THIS CAUSES LEAKAGE FROM THE TUBE. AS A RESULT THE PATIENT REQUIRES THE TUBE TO BE REMOVED AND REPLACED. THIS IS HIGHLY TRAUMATIC FOR PEDIATRIC PATIENTS. THIS ISSUE HAS OCCURRED 3 TIMES FOR THIS PARTICULAR PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1006262 KANGAROO TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT COVIDIEN 8884721088E 1810789864 10884521582996

    Patients

    Seq Age Sex Outcome Treatment
    1