BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROCUFF SUBGLOTTIC SUCTIONING ENDOTRACHEAL TUBE, 7.0 MM, ORAL

    MDR report key: 11682795 · Received April 16, 2021

    Report

    Report Number
    9611594-2021-00056
    Event Type
    Malfunction
    Date Received
    April 16, 2021
    Date of Event
    March 3, 2021
    Report Date
    June 7, 2021
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    BTR
    UDI-DI
    00609038132204
    PMA / PMN Number
    K131254
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUBJECT SAMPLE PROVIDED WAS EVALUATED AND NO FAILURES WERE DETECTED IN THE DEVICE RETURNED; AVANOS MEDICAL, INC. WASUNABLE TO CONFIRM OR DUPLICATE THE REPORTED INCIDENT. A ROOT CAUSE WAS NOT IDENTIFIED. ALL INFORMATION REASONABLY KNOWN AS OF 07-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 COMP-GHC-21-00876. 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 NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. ALL INFORMATION REASONABLY KNOWN AS OF 16-APR-2021 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 AVANOS MEDICAL, INC. COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). .

    Description of Event or Problem · 1

    IT WAS REPORTED THE CLINICIANS HEARD AIR AROUND THE CUFF WITH A NOTED POSSIBLE LEAK. THE DEVICE WAS REPLACED. ADDITIONAL INFORMATION RECEIVED 07-APR-2021 NOTED THE DEVICE WAS NOTED ALTERED IN ANY WAY PRIOR TO USE. THE DEVICE HAD BEEN IN USE FOR SEVEN DAYS WHEN PROBLEM WAS NOTED. THE CUFF WAS FILLED WITH 20CC OF AIR. THE PATIENT'S CURRENT STATUS AS IT RELATES TO THE REPORTED INCIDENT IS "UNKNOWN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579018 MICROCUFF SUBGLOTTIC SUCTIONING ENDOTRACHEAL TUBE, 7.0 MM, ORAL VAP MICROCUFF ENDOTRACHEAL TUBES BTR AVANOS MEDICAL INC. 13220 UNKNOWN 00609038132204

    Patients

    Seq Age Sex Outcome Treatment
    1