BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROCUFF ADULT ENDOTRACHEAL TUBE

    MDR report key: 16848603 · Received May 1, 2023

    Report

    Report Number
    3011270181-2023-00035
    Event Type
    Injury
    Date Received
    May 1, 2023
    Date of Event
    April 4, 2023
    Report Date
    October 30, 2023
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    BTR
    UDI-DI
    00609038352152
    PMA / PMN Number
    K113333
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD FOR LOT CM2089001 WAS REVIEWED AND THE PRODUCT WAS PRODUCED ACCORDING TO PRODUCT SPECIFICATIONS. ALL INFORMATION REASONABLY KNOWN AS OF 26 OCT 2023 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 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 · 0

    H6: 4581-APPROPRIATE HEALTH EFFECT-CLINICAL CODE/TERM NOT AVAILABLE: LOST POSITIVE END-EXPIRATORY PRESSURE (PEEP) AND LUNG DE-RECRUITMENT. THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD IS IN-PROGRESS. ALL INFORMATION REASONABLY KNOWN AS OF 28 APR 2023 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 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. H3 OTHER TEXT : DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT PATIENTS. THIS IS THE SECOND OF THREE REPORTS. REFER TO 3011270181-2023-00034 FOR THE FIRST REPORT. REFER TO 3011270181-2023-00036 FOR THE THIRD REPORT. IT WAS REPORTED, THE CONNECTOR ON THE ENDOTRACHEAL TUBE (ETT) CAME OFF AND CAUSED THE PATIENT TO BE DISCONNECTED FROM THE VENT; THE PATIENT LOST POSITIVE END-EXPIRATORY PRESSURE (PEEP) AND THEIR LUNGS DE-RECRUITED; THE PATIENT WAS REINTUBATED WITH A DIFFERENT ETT. THE PATIENT¿S CURRENT CONDITION WAS NOT REPORTED ADDITIONAL INFORMATION RECEIVED 14APR2023 REPORTED, THE EVENT HAPPENED ON (B)(6) 2023; THE PATIENT REPORTED TO BE FINE AFTER BEING REINTUBATED WITH AN ETT FROM A DIFFERENT MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124241 MICROCUFF ADULT ENDOTRACHEAL TUBE VAP MICROCUFF ENDOTRACHEAL TUBES BTR AVANOS MEDICAL INC. 35215 CM2089001 00609038352152

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention