BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNSPECIFIED ENDOTRACH TUBE

    MDR report key: 12791925 · Received November 11, 2021

    Report

    Report Number
    8020889-2021-00131
    Event Type
    Death
    Date Received
    November 11, 2021
    Date of Event
    September 14, 2021
    Report Date
    February 11, 2022
    Manufacturer
    TUBE, TRACHEAL (W/WO CONNECTOR)
    Product Code
    BTR
    UDI-DI
    60884522006724
    PMA / PMN Number
    K051416
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL CODES. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. 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 AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE 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 REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM 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 · 0

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

    Description of Event or Problem · 0

    ACCORDING TO THE REPORTER, A COVID PATIENT WAS UNABLE TO BE VENTILATED. RAPID SEQUENCE WAS PERFORMED WITH AN ENDOTRACHEAL TUBE. THE PATIENT ARRESTED WITH MULTIPLE CODES AND PASSED AWAY.

    Description of Event or Problem · 0

    ACCORDING TO THE REPORTER, DURING USE, THE DEVICE HAD FAILED IN A VERY ILL PATIENT. THE PHYSICIAN WAS UNABLE TO VENTILATE THE PATIENT AND SATURATION LEVELS DROPPED. THE PATIENT PASSED AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1695391 UNSPECIFIED ENDOTRACH TUBE TUBE, TRACHEAL (W/WO CONNECTOR) BTR TUBE, TRACHEAL (W/WO CONNECTOR) UNSPECIFIED ENDOTRACH TUBE 60884522006724
    1695392 UNSPECIFIED ENDOTRACH TUBE TUBE, TRACHEAL (W/WO CONNECTOR) BTR TUBE, TRACHEAL (W/WO CONNECTOR) UNSPECIFIED ENDOTRACH TUBE 60884522006724

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Unknown Other| D