BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BALLARD

    MDR report key: 23877676 · Received December 23, 2025

    Report

    Report Number
    8030647-2025-00138
    Event Type
    Malfunction
    Date Received
    December 23, 2025
    Date of Event
    November 3, 2025
    Report Date
    April 24, 2026
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    BSY
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    003

    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 IN-PROGRESS. ALL INFORMATION REASONABLY KNOWN AS OF 23 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, DURING TUBE PATCHING AND POSITIONING, WE DISCOVERED A TEAR IN THE Y-PIECE CONNECTING THE TUBE TO THE SUCTION SYSTEM; WHEN REPLACING THE TUBE, THE PIECE BROKE AND LEFT A SMALL PIECE IN THE TUBE THAT COULD NOT BE REMOVED WITH A KOCHER. THERE WAS LITTLE TIME TO CONTINUE TESTING BECAUSE THE PATIENT COULD NOT GO WITHOUT VENTILATION FOR LONG. THE TUBE WAS CUT AND A SMALLER Y-PIECE WAS INSERTED. THERE WAS NO REPORT OF A DELAY IN THERAPY, HARM OR INJURY AS A RESULT OF THIS REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2531948 BALLARD BALLARD CLOSED SUCTION SYSTEM FOR NEONATES/PEDIATRICS, Y-ADAPTER, ENDOTRACHEAL BSY AVANOS MEDICAL INC. 197-5 1579559

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown