BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHILEY

    MDR report key: 8032618 · Received November 2, 2018

    Report

    Report Number
    2936999-2018-00665
    Event Type
    Injury
    Date Received
    November 2, 2018
    Report Date
    February 27, 2019
    Manufacturer
    MMJ SA DE CV (USD)
    Product Code
    BTO
    UDI-DI
    40884522005372
    PMA / PMN Number
    K945407
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    EVALUATION SUMMARY: ONE SAMPLE WAS RECEIVED FOR EVALUATION. A VISUAL INSPECTION WAS PERFORMED AND NO CUTS, DEFORMITIES OR DAMAGE WAS OBSERVED IN THE MEM BRANE NOR THE DIAPHRAGM, THE MEMBRANE IS IN THE RIGHT POSITION. THEREFORE, NO FAILURE MODE WAS OBSERVED IN THE RECEIVED SAMPLE SINCE MET WITH THE PRODUCT SPECIFICATIONS AND NO CORRECTIVE ACTIONS ARE REQUIRED. INFORMATION HAS BEEN ADDED TO THE DATABASE AND TRENDS WILL CONTINUE TO BE MONITORED. 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. 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

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, THE UNITS WERE GENERATING A 'SSSSST" SOUND WHEN IT'S BEING USED. THE CUSTOMER REPORTED THAT THE PATIENT HAD DIFFICULTY BREATHING WHEN USING THE DEVICE.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, THE UNITS WERE GENERATING A 'SSSSST" SOUND WHEN IT'S BEING USED. THE CUSTOMER REPORTED THAT THE PATIENT HAD DIFFICULTY BREATHING WHEN USING THE DEVICE. IT WAS ALSO REPORTED THAT THE PATIENT COULD BREATHE DAILY WITH 4 LITERS OXYGEN SUPPORT IN SPEAKING VALVE. IT WAS ALSO REPORTED THAT THE TUBE WAS CUFFED, FENESTRATED AND DEFLATED, EACH SPEAKING VALVE WAS IMMEDIATELY REMOVED AS IT WAS OBSERVED AFTER A FEW MINUTES THAT DEVICE DID NOT WORK NORMALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    873257 SHILEY TUBE, TRACHEOSTOMY (W/WO CONNECTOR) BTO MMJ SA DE CV (USD) SSVO 17A0573JZX 40884522005372

    Patients

    Seq Age Sex Outcome Treatment
    1 Other