BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BALLARD

    MDR report key: 24464109 · Received February 26, 2026

    Report

    Report Number
    8030647-2026-00012
    Event Type
    Malfunction
    Date Received
    February 26, 2026
    Date of Event
    January 26, 2026
    Report Date
    May 21, 2026
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    BSY
    UDI-DI
    10889483563731
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT INVOLVED IN THE REPORT HAS NOT BEEN RECEIVED FOR EVALUATION A REVIEW OF THE DEVICE HISTORY RECORD IS IN-PROGRESS. ALL INFORMATION REASONABLY KNOWN AS OF 26 FEB 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, WHEN THE NURSE ATTEMPTED TO TURN THE SUCTION CONTROL KNOB [ON THE CLOSED SUCTION SYSTEM] DURING INVASIVE VENTILATION USING A VYGON TUBE AND A WILAMED BREATHING CIRCUIT, THE CONTROL KNOB GAVE WAY AND THE PATIENT'S VENTILATION WAS INTERRUPTED FOR AN EXTENDED [UNSPECIFIED] PERIOD OF TIME. THE SYSTEM WAS REPLACED. THERE WAS NO REPORT OF HARM OR INJURY AS A RESULT OF THIS REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281281 BALLARD BALLARD NN PED Y ADTR NDEHP,8FR,20 BSY AVANOS MEDICAL INC. 98386 1594072 10889483563731

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown