BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN CLOSED SUCTION SYSTEM

    MDR report key: 23824402 · Received December 16, 2025

    Report

    Report Number
    8030647-2025-00140
    Event Type
    Injury
    Date Received
    December 16, 2025
    Date of Event
    November 3, 2025
    Report Date
    December 16, 2025
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    BSY
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT INVOLVED IN THE REPORT HAS NOT BEEN RETURNED FOR EVALUATION. THE UDI-DI-PI IS NOT AVAILABLE AS NO STOCK/PRODUCT CODE OR LOT NUMBER WAS PROVIDED. ALL INFORMATION REASONABLY KNOWN AS OF 16 DEC 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 THAT THE PATIENT'S NURSE WAS SUCTIONING THE PATIENT WHEN THE CATHETER BROKE AND BECAME LODGED IN THE PATIENT'S TRACHEA. THE PATIENT'S MOTHER CALLED 911, AND THE PATIENT WAS TRANSPORTED TO THE EMERGENCY DEPARTMENT/ICU, WHERE A PROCEDURE WAS PERFORMED TO REMOVE THE CATHETER. THE PATIENT WAS ADMITTED FOR SIX DAYS AND DISCHARGED ON (B)(6) 2025. THE PATIENT'S CURRENT CONDITION WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2038765 UNKNOWN CLOSED SUCTION SYSTEM UNKNOWN CLOSED SUCTION SYSTEM BSY AVANOS MEDICAL INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| L| H