BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BALLARD CLOSED SUCTION SYSTEM

    MDR report key: 24645111 · Received March 19, 2026

    Report

    Report Number
    8030647-2025-00047
    Event Type
    Malfunction
    Date Received
    March 19, 2026
    Report Date
    March 17, 2025
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    BSY
    UDI-DI
    00609038983844
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION; ADDITIONALLY, NO PHOTOGRAPHIC /VIDEO EVIDENCE WAS PROVIDED. WITHOUT PHOTOGRAPHIC /VIDEO EVIDENCE THE COMPLAINT COULD NOT BE CONFIRMED; WITHOUT A SAMPLE TO PERFORM FUNCTIONAL EVALUATION, A ROOT CAUSE COULD NOT BE DETERMINED. THE DEVICE HISTORY RECORD FOR LOT 30327760 WAS REVIEWED AND THE PRODUCT WAS PRODUCED ACCORDING TO PRODUCT SPECIFICATIONS. ALL INFORMATION REASONABLY KNOWN AS OF 17 MAR 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 (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. THE FDA INITIAL REPORT FOR MW REPORT MW 8030647-2025-00047 WAS SUBMITTED ON 24APR2025 AND THE FOLLOWING ACK2 WAS RECEIVED CONFIRMING ASUCCESSFUL ESG SUBMISSION: SUBMISSION CI250424193054.AC33F7C6CCAE4B8BBBAE0B8091111199 HAS BEEN SUCCESSFULLY TRANSMITTED TO CDRH CORE ID: CI250424193054.AC33F7C6CCAE4B8BBBAE0B8091111199,

    Description of Event or Problem · 0

    IT WAS REPORTED, THE NEW IN-LINE SUCTION CATHETER (CSC) WAS ATTACHED TO THE ENDOTRACHEAL TUBE (ETT). IT WAS NOTED THAT UPON THE SECOND USE OF THE CSC IT HAD FILLED WITH AIR, THE VENTILATOR ALARMED HIGH LEAK, AND THE PATIENT DESATURATED. THE PORT WAS TURNED ON AND OFF, THE CSC WAS REMOVED AND THE DEVICE WAS REPLACED. THERE WAS NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702324 BALLARD CLOSED SUCTION SYSTEM BALLARD CLOSED SUCTION CATHETER, Y-ADAPTER, NEONATAL/PEDIATRIC BSY AVANOS MEDICAL INC. 98384 30327760 00609038983844

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown