BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROCUFF SUBGLOTTIC SUCTIONING ADULT ENDOTRACHEAL TUBE

    MDR report key: 11732070 · Received April 27, 2021

    Report

    Report Number
    9611594-2021-00065
    Event Type
    Malfunction
    Date Received
    April 27, 2021
    Date of Event
    March 31, 2021
    Report Date
    June 16, 2021
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    BTR
    UDI-DI
    00609038132211
    PMA / PMN Number
    K131254
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: A3, A4, B7. THE INVESTIGATION REMAINS IN PROGRESS. ALL INFORMATION REASONABLY KNOWN AS OF 18 MAY 2021 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 COMP-GHC-21-01083. 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 · 0

    THE DEVICE HISTORY RECORD FOR LOT 20037337 WAS REVIEWED AND THE PRODUCT WAS PRODUCED ACCORDING TO PRODUCT SPECIFICATIONS. THE ACTUAL COMPLAINT PRODUCT WAS RETURNED FOR EVALUATION. A TEAR WAS OBSERVED IN THE CUFF. NO DAMAGE WAS OBSERVED ON ANY OTHER PORTION OF THE DEVICE. THE ROOT CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. ALL INFORMATION REASONABLY KNOWN AS OF 16 JUN 2021 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

    HEALTH EFFECT - IMPACT (B)(4): APPROPRIATE HEALTH IMPACT TERM/CODE NOT AVAILABLE: REINTUBATED A REVIEW OF THE DEVICE HISTORY RECORD IS IN-PROGRESS. THE SAMPLE IS REPORTED TO BE AVAILABLE, BUT HAS NOT YET BEEN RECEIVED BY THE MANUFACTURER. ALL INFORMATION REASONABLY KNOWN AS OF 26 APR 2021 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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUFF FAILED TO HOLD ON THE ENDOTRACHEAL TUBE. THE PATIENT WAS REINTUBATED WITHOUT ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630178 MICROCUFF SUBGLOTTIC SUCTIONING ADULT ENDOTRACHEAL TUBE VAP MICROCUFF ENDOTRACHEAL TUBES BTR AVANOS MEDICAL INC. 13221 20037337 00609038132211

    Patients

    Seq Age Sex Outcome Treatment
    1