BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHILEY

    MDR report key: 5721873 · Received June 13, 2016

    Report

    Report Number
    2936999-2016-00477
    Event Type
    Malfunction
    Date Received
    June 13, 2016
    Report Date
    May 14, 2025
    Manufacturer
    COVIDIEN
    Product Code
    JOH
    PMA / PMN Number
    K051416
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC REFERENCE # (B)(4). UPDATED PATIENT INFORMATION IN SECTION A, AS WELL AS B7, MEDICAL CONDITIONS. ADDITIONALLY, IT WAS REPORTED THAT THE PATIENT'S BMI WAS 55.04 KG/M.

    Additional Manufacturer Narrative · 0

    MEDTRONIC REFERENCE # (B)(4). UPDATED PATIENT INFORMATION IN SECTION A, AS WELL AS B7, MEDICAL CONDITIONS. ADDITIONALLY, IT WAS REPORTED THAT THE PATIENTS BMI WAS 55.04 KG/M. 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

    COVIDIEN/MEDTRONIC REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PHYSICIAN LATER REPORTED THE PATIENT IN THIS EVENT DID REQUIRE RECANNULATION WITH ANOTHER TUBE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE TRACHEOSTOMY TUBE THE PATIENT WAS USING LEAKED AND THE CUFF REPEATEDLY DEFLATED OR LOST PRESSURE BEFORE 3 MONTHS OF USE. THE EXACT NUMBER OF DAYS USED IS UNKNOWN, HOWEVER THE CUSTOMER WAS INFORMED THAT USE SHOULD NOT EXCEED 29 DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    374348 SHILEY 6.0MM XLT TRACH CUFF DIST JOH COVIDIEN 60XLTCD

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male Required Intervention