BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVANOS MEDICAL, INC.

    MDR report key: 25250181 · Received May 21, 2026

    Report

    Report Number
    3011270181-2026-20006
    Event Type
    Malfunction
    Date Received
    May 21, 2026
    Date of Event
    April 22, 2026
    Report Date
    May 21, 2026
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    BTR
    UDI-DI
    00609038351162
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION; HOWEVER, THE REPORTER PROVIDED PHOTOGRAPHIC/VIDEOGRAPHIC EVIDENCE; ANALYSIS OF THE PHOTOGRAPHIC EVIDENCE CONFIRMED THE COMPLAINT AS REPORTED. 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 21 MAY 2026 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 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 SUN MED HOLDINGS LLC. PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY.

    Description of Event or Problem · 0

    IT WAS REPORTED, AFTER COMPLETION OF THE PROCEDURE, DURING EXTUBATION OF THE PATIENT THE ENDOTRACHEAL TUBE (ETT) KINKED AND THEY WERE UNABLE TO THE SUCTION PATIENT. TO RESOLVE THE ISSUE, THE RESPIRATORY THERAPIST (RT) PUT THEIR FINGER DOWN THE BACK OF THE PATIENT'S THROAT TO STRAIGHTEN OUT THE KINK; HOWEVER, AS SOON AS SHE REMOVED HER FINGER, IT IMMEDIATELY BENT AGAIN. THERE WAS NO REPORT OF SERIOUS HARM OR INJURY AS A RESULT OF THIS REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295884 AVANOS MEDICAL, INC. MICROCUFF PEDIATRIC ENDOTRACHEAL TUBE, ORAL/NASAL MAGILL BTR AVANOS MEDICAL INC. 35116 UNKNOWN 00609038351162

    Patients

    Seq Age Sex Outcome Treatment
    1