BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVANOS MEDICAL, INC.

    MDR report key: 22155518 · Received June 5, 2025

    Report

    Report Number
    3011270181-2025-20003
    Event Type
    Injury
    Date Received
    June 5, 2025
    Date of Event
    April 28, 2025
    Report Date
    June 5, 2025
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    BTR
    UDI-DI
    10609038351121
    PMA / PMN Number
    K080821
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT INVOLVED IN THE REPORT HAS NOT BEEN RETURNED FOR EVALUATION 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. ALL INFORMATION REASONABLY KNOWN AS OF 05 JUN 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 SUN MED HOLDINGS LLC. 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 SUN MED HOLDINGS LLC. SUN MED HOLDINGS LLC. 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 SUN MED HOLDINGS COMPLAINT DATABASE AND IDENTIFIED AS (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 SUN MED HOLDINGS LLC. PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY.

    Description of Event or Problem · 0

    IT WAS REPORTED, CALLED INTO PATIENT'S ROOM DUE TO REGISTERED NURSE (RN) BAGGING PATIENT. RN MENTIONED A LEAK IN THE ENDOTRACHEAL TUBE (ETT), RESPIRATORY THERAPIST (RT) CHECKED TUBE PLACEMENT, AND IT WAS A LITTLE HIGH WHERE IT WAS SUPPOSED TO BE PLACED. BOTH RT AND OTHER RT RETAPED THE TUBE TO THE CORRECT POSITION WHICH WAS 9 AT THE GUM AND A CHEST XRAY (CXR) WAS TAKEN FOR TUBE PLACEMENT. UPON X-RAY THE TUBE WAS HIGH AND CONFIRMED BY ADVANCED PRACTICE NURSE (APN). THE TUBE WAS THEN PUSHED IN TO 10 AND ANOTHER X-RAY WAS TAKEN. UPON X-RAY THE TUBE WAS STILL HIGH WHICH WAS CONFIRMED BY APN AND SO THE TUBE WAS ONCE AGAIN PUSHED TO 11. THE X-RAY STILL SHOWED IT WAS HIGH. THE PATIENT'S SATURATIONS WERE LOWER, SO THE ATTENDING MEDICAL DOCTOR (MD) AND OTHER APN WAS CALLED TO THE ROOM TO REVIEW X-RAYS AS WELL. MD ASKED FOR THE CLINICAL MEDICAL ASSISTANT CERTIFIED (CMAC) TO USE TO OBSERVE WHAT WAS GOING ON WITH THE ETT INSIDE THE PATIENT'S MOUTH. ONCE THE BLADE WAS IN USE, THE CAMERA SHOWED THE ETT WAS THROUGH THE VOCAL CORDS SHOWING THE ETT WAS STILL IN PLACE, BUT DUE TO THE PATIENT DESATSURATIONS AND BRADY, THE DECISION WAS MADE TO SWITCH OUT THE TUBES JUST IN CASE THERE WAS SOMETHING DEFECTIVE WITH THE TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1479624 AVANOS MEDICAL, INC. MICROCUFF PEDIATRIC ENDOTRACHEAL TUBE, ORAL/NASAL MAGILL BTR AVANOS MEDICAL INC. 35112 UNKNOWN 10609038351121

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female