BEUDAMED
    FDA Adverse Event Death Summary report: N

    MICROCUFF SUBGLOTTIC SUCTIONING ADULT ENDOTRACHEAL TUBE

    MDR report key: 9716327 · Received February 17, 2020

    Report

    Report Number
    9611594-2020-00029
    Event Type
    Death
    Date Received
    February 17, 2020
    Date of Event
    December 24, 2019
    Report Date
    August 12, 2020
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    BTR
    UDI-DI
    10680651132205
    PMA / PMN Number
    K131254
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD FOR LOT: AA9147V01 WAS REVIEWED AND THE PRODUCT WAS PRODUCED ACCORDING TO PRODUCT SPECIFICATIONS. THE ACTUAL COMPLAINT PRODUCT WAS RETURNED FOR EVALUATION. NO LEAKAGES, VISIBLE TEARING ON THE CUFF, OR DAMAGES WERE DETECTED IN THE RETURNED DEVICE. ROOT CAUSE COULD NOT BE DETERMINED. ALL INFORMATION REASONABLY KNOWN AS OF 12 AUG 2020 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 AVANOS MEDICAL INC. COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT: (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN AVANOS MEDICAL INC. PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY.

    Additional Manufacturer Narrative · 1

    THE PRODUCT INVOLVED IN THE REPORT HAS BEEN RETURNED AND IS BEING PROCESSED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD IS IN-PROGRESS. ALL INFORMATION REASONABLY KNOWN AS OF 14 FEB 2020 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 AVANOS MEDICAL INC. COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN AVANOS MEDICAL INC. PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE "ETT [ENDOTRACHEAL TUBE] CUFF HAD A LEAK. THE PATIENT CODED AND DID NOT MAKE IT." ADDITIONAL INFORMATION RECEIVED 06-FEB-2020 INDICATED THE DEVICE WAS USED ON AN ADULT DURING CARDIAC ARREST. THE TUBE WAS CHECKED PRIOR TO USE, HOWEVER, THE CUFF HAD TO BE REFILLED NUMEROUS TIMES WHEN IN PLACE. FINALLY THE SYRINGE WAS HELD ON THE PILOT BALLOON TO MAINTAIN A SEAL. THE USER FACILITY NOTICED A SUBSTANTIAL LEAK WHEN THEY DID NOT MANUALLY ENSURE THAT THE PILOT WAS SEALED. THE PATIENT WAS MANUALLY VENTILATED WITH A BMV [BAG MASK VENTILATION]. THE LEAK WAS OBVIOUS DURING POSITIVE PRESSURE VENTILATION WITH THE BMV. THE ETT WAS RECHECKED FOR POSITIONING WHICH CONFIRMED GOOD PLACEMENT. THE USER FACILITY STATED THEY WERE ABLE TO ADEQUATELY VENTILATE WHEN ENSURING THAT THE PILOT WAS SEALED WITH A SYRINGE THAT WAS HELD IN PLACE AND THE PLUNGER KEPT DEPRESSED. THE PATIENT WAS ADEQUATELY VENTILATED DURING THE ARREST BUT "ONLY WITH OUR INTERVENTION WITH THE SYRINGE." ADDITIONAL INFORMATION RECEIVED 07-FEB-2020 INDICATED THE PATIENT DID NOT "CODE" AS A RESULT OF THE CUFF LEAKING. THE USER FACILITY STATED "IT WAS ONLY DURING THE CODE EVENT WITH THE PATIENT THAT IT WAS NOTED THAT THE ET TUBE CUFF WOULD NOT REMAIN INFLATED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    180806 MICROCUFF SUBGLOTTIC SUCTIONING ADULT ENDOTRACHEAL TUBE VAP MICROCUFF ENDOTRACHEAL TUBES BTR AVANOS MEDICAL INC. 13220 AA9147V01 10680651132205

    Patients

    Seq Age Sex Outcome Treatment
    1 Death