BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROCUFF ENDOTRACHEAL TUBE - ADULT-10.2-7.5-24

    MDR report key: 14173118 · Received April 21, 2022

    Report

    Report Number
    3011270181-2022-00026
    Event Type
    Malfunction
    Date Received
    April 21, 2022
    Date of Event
    March 21, 2022
    Report Date
    May 20, 2022
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    BTR
    UDI-DI
    00609038352152
    PMA / PMN Number
    K113333
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 20-APR-2022 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).

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD FOR LOT CM1215001 WAS REVIEWED AND THE PRODUCT WAS PRODUCED ACCORDING TO PRODUCT SPECIFICATIONS. ONE USED SAMPLE WAS RETURNED FOR EVALUATION. EVALUATION OF THE SAMPLE REVEALED NO DAMAGE OR DEFORMATION THAT WOULD INDICATE THE REPORTED "KINKS". THE DEVICE FUNCTIONED AS EXPECTED. THE COMPLAINT COULD NOT BE CONFIRMED AS REPORTED. THE ROOT CAUSE COULD NOT BE DETERMINED. ALL INFORMATION REASONABLY KNOWN AS OF 19 MAY 2022 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THE "ET [ENDOTRACHEAL TUBE] TUBE KINKED AT THE 12-14MM." PATIENT REQUIRED ET TUBE BE EXCHANGED. THE PATIENT WAS IN "BEACH CHAIR" POSITION - MEANING SITTING UP WITH HEAD IN A NEUTRAL POSITION. THE PATIENT WAS REINTUBATED WITHOUT COMPLICATIONS AND THE SURGICAL PROCEDURE WAS COMPLETED THERE WAS NO REPORTED INJURY. ADDITIONAL INFORMATION RECEIVED 29-MAR-2022 STATED THE PATIENT WAS TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION. THE ET TUBE WAS NOT ALTERED PRIOR TO THE REPORTED INCIDENT. IT WAS UNKNOWN HOW LONG THE ET TUBE HAD BEEN IN PLACE PRIOR TO THE EVENT AND SUBSEQUENT REPLACEMENT OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1956766 MICROCUFF ENDOTRACHEAL TUBE - ADULT-10.2-7.5-24 VAP CLOSED SUCTION CATHETERS & ACCESSORIES BTR AVANOS MEDICAL INC. 35215 CM1215001 00609038352152

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown