BEUDAMED
    FDA Adverse Event Death Summary report: N

    MICROCUFF SUBGLOTTIC SUCTIONING ADULT ENDOTRACHEAL TUBE

    MDR report key: 8640142 · Received May 24, 2019

    Report

    Report Number
    9611594-2019-00100
    Event Type
    Death
    Date Received
    May 24, 2019
    Date of Event
    April 28, 2019
    Report Date
    July 10, 2019
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    BTR
    UDI-DI
    10680651132229
    PMA / PMN Number
    K131254
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD FOR LOT AA8281V01 WAS REVIEWED AND THE PRODUCT WAS PRODUCED ACCORDING TO PRODUCT SPECIFICATIONS. THE ACTUAL COMPLAINT PRODUCT WAS RETURNED FOR EVALUATION. ONE USED SAMPLE WAS RECEIVED WITHOUT PRODUCT PACKAGING. THE LEAK WAS DETERMINED TO BE AT THE PROXIMAL END OF THE CUFF. A DEFINITIVE ROOT CAUSE WAS NOT DETERMINED. ALL INFORMATION REASONABLY KNOWN AS OF 10 JUL 2019 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY AVANOS MEDICAL INC. REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO AVANOS MEDICAL INC.. AVANOS MEDICAL INC. HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE HALYARD HEALTH COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4).

    Additional Manufacturer Narrative · 1

    THE SAMPLE IS REPORTED TO BE AVAILABLE, BUT HAS NOT YET BEEN RECEIVED BY THE MANUFACTURER. A REVIEW OF THE DEVICE HISTORY RECORD IS IN-PROGRESS. ALL INFORMATION REASONABLY KNOWN AS OF 24 MAY 2019 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. AVANOS MEDICAL INC. HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE HALYARD HEALTH COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "PATIENT WAS INTUBATED, CUFF PRESSURE DROPPED AND THE TUBE HAD TO BE REMOVED, ON EXAMINATION IT WAS THE CUFF HAD COME LOOSE AT THE SEAL WITH THE ET [ENDOTRACHEAL] TUBE. PATIENT DID DIE ON THE NEXT DAY, HOWEVER NOT RELATED TO THIS INCIDENT WITH THE ET TUBE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434559 MICROCUFF SUBGLOTTIC SUCTIONING ADULT ENDOTRACHEAL TUBE VAP MICROCUFF ENDOTRACHEAL TUBES BTR AVANOS MEDICAL INC. 13222 AA8281V01 10680651132229

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Death