BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVANOS MEDICAL, INC.

    MDR report key: 24877841 · Received April 14, 2026

    Report

    Report Number
    8030647-2026-00018
    Event Type
    Malfunction
    Date Received
    April 14, 2026
    Report Date
    April 14, 2026
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    BSY
    UDI-DI
    00609038983868
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT INVOLVED IN THE REPORT HAS NOT BEEN RETURNED FOR EVALUATION; HOWEVER, THE REPORTER PROVIDED A PHOTOGRAPH OF THE DEVICE IN QUESTION WHICH CLEARLY DEPICTS THE REPORTED CONDITION BROKEN//ADAPTOR; THE COMPLAINT IS CONSIDERED CONFIRMED. THE ISSUE OF BROKEN//ADAPTOR WAS INVESTIGATED AND THE ROOT CAUSE WAS IDENTIFIED AS DAMAGE OCCURRING DURING THE ASSEMBLY PROCESS; CORRECTIVE ACTIONS HAVE BEEN IMPLEMENTED TO THE ASSEMBLY PROCESS AS WELL AS IMPROVEMENTS WERE MADE TO THE MATERIAL HANDLING SYSTEM IN ORDER TO PREVENT THE COMPONENTS FROM BEING DAMAGED DURING THE PROCESS. WE CONTINUE TO MONITOR FOR TRENDS. THE DEVICE HISTORY RECORD FOR LOT 30302335 WAS REVIEWED AND THE PRODUCT WAS PRODUCED ACCORDING TO PRODUCT SPECIFICATIONS. ALL INFORMATION REASONABLY KNOWN AS OF 14 APR 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.

    Description of Event or Problem · 0

    SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT PATIENTS. THIS IS THE FIRST OF THREE REPORTS. REFER TO 8030647-2026-00019 FOR THE SECOND REPORT. REFER TO 8030647-2026-00020 FOR THE THIRD REPORT. IT WAS REPORTED; THE RESPIRATORY THERAPIST (RT) ATTENDED THE PATIENT AND NOTED A LEAKING SOUND BETWEEN THE ENDOTRACHEAL TUBE (ETT) AND THE Y ADAPTOR FOR THE INLINE SUCTION [CATHETER]. THE Y ADAPTOR [WAS FOUND TO BE] BROKEN LEAVING THE TIP PIECE INSIDE THE ETT. THE PATIENT WAS IMMEDIATELY ATTENDED TO; A NEW ADAPTOR AND INLINE SUCTION WERE PLACED. 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
    937294 AVANOS MEDICAL, INC. BALLARD CLOSED SUCTION CATHETER, Y-ADAPTER, NEONATAL/PEDIATRIC BSY AVANOS MEDICAL INC. 98386 30302335 00609038983868

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown