BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVANOS, VAP MICROCUFF ENDOTRACHEAL TUBES

    MDR report key: 20844794 · Received December 4, 2024

    Report

    Report Number
    3011270181-2024-00128
    Event Type
    Injury
    Date Received
    December 4, 2024
    Report Date
    January 9, 2025
    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
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION; WITHOUT A SAMPLE TO PERFORM FUNCTIONAL EVALUATION A ROOT CAUSE CANNOT BE DETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD IS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. THE DOCUMENTED UDI IS BASED ON THE STOCK/PRODUCT CODE PROVIDED BY THE REPORTER; THE UDI-PI IS NOT AVAILABLE AS NO LOT NUMBER WAS PROVIDED FOR THE ALLEGED DEVICE. ALL INFORMATION REASONABLY KNOWN AS OF 03 DEC 2024 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

    THE ACTUAL COMPLAINT PRODUCT WAS NOT AVAILABLE FOR RETURN; HOWEVER, THE REPORTER PROVIDED PHOTOGRAPH(S) OF THE ALLEGED DEVICE. THE IMAGE(S) PROVIDED WERE REVIEWED AND THE REPORTED ISSUE OF, KINKED TUBE WAS CONFIRMED. HOWEVER, WITHOUT A SAMPLE TO PERFORM FUNCTIONAL EVALUATION A ROOT CAUSE CANNOT BE DETERMINED. BASED ON THE STOCK CODE, NO DEVIATION WAS FOUND DURING THE REVISION OF THE MANUFACTURING PROCESS. ALL INFORMATION REASONABLY KNOWN AS OF 08 JAN 2025 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

    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 FIRST OF THREE REPORTS. REFER TO 3011270181-2024-00129 FOR THE SECOND REPORT REFER TO 3011270181-2024-00130 FOR THE THIRD REPORT. IT WAS REPORTED, THE TUBE KINKED IN THE PATIENT¿S AIRWAY/TRACHEA, WHICH WAS DISCOVERED WHEN THEY WERE UNABLE TO PASS THE INLINE SUCTION CATHETER DURING BRONCHOSCOPY AND UNABLE TO PERFORM ROUTINE SUCTIONING. IT WAS ADDITIONALLY REPORTED, THE PATIENT DEVELOPED A RIGHT-SIDE PNEUMONIA AND UNDERWENT SEVERAL UNSUCCESSFUL EMERGENCY BRONCHOSCOPIES TO TRY TO FIX THE KINK. NO ADDITIONAL INFORMATION CONCERNING THE PATIENT¿S CONDITION OR CARE WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1871370 AVANOS, VAP MICROCUFF ENDOTRACHEAL TUBES MICROCUFF ADULT ENDOTRACHEAL TUBE BTR AVANOS MEDICAL INC. 35215 UNKNOWN 00609038352152

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other