BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BALLARD CLOSED SUCTION SYSTEM

    MDR report key: 22472425 · Received July 10, 2025

    Report

    Report Number
    8030647-2025-00068
    Event Type
    Injury
    Date Received
    July 10, 2025
    Date of Event
    June 6, 2025
    Report Date
    September 12, 2025
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    BSY
    UDI-DI
    00609038983837
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    117

    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. ANALYSIS OF PHOTOGRAPHIC EVIDENCE PROVIDED BY THE REPORTER. ALL INFORMATION REASONABLY KNOWN AS OF 10 JUL 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.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION-INVESTIGATION COMPLETION: D4; H2; H6. THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION; HOWEVER, THE REPORTER PROVIDED PHOTOGRAPHIC/VIDEOGRAPHIC EVIDENCE; ANALYSIS OF THE PHOTOGRAPHIC EVIDENCE CONFIRMED THE COMPLAINT AS REPORTED; THE ROOT CAUSE WAS DETERMINED TO BE MANUFACTURING RELATED. ACTIONS WERE TAKEN TO PREVENT THIS ISSUE FROM RECURRING INCLUDING RETRAINING OF THE OPERATORS FOR VISUAL INSPECTIONS EVERY HOUR; WE CONTINUE TO MONITOR FOR TRENDS. THE DEVICE HISTORY RECORD FOR LOT 30324932 WAS REVIEWED AND THE PRODUCT WAS PRODUCED ACCORDING TO PRODUCT SPECIFICATIONS. ALL INFORMATION REASONABLY KNOWN AS OF 12 SEP 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 21 CFR 803, 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, THE CATHETER COULD NOT BE PASSED THROUGH THE END TIP AS THE HOLE WAS TOO NARROW FOR THE CATHETER. THE PATIENT WHO WAS UNSTABLE AT THE TIME, REMAINED ON VENTILATION AS A NEW ATTEMPT WAS MADE WITH A DIFFERENT CLOSED SUCTION CATHETER (CSC). THE QUICK ACTIONS OF THE STAFF ENABLED THE PATIENT TO BE SUCCESSFULLY SUCTIONED AFTER WHICH THE PATIENT FELT BETTER. THE PATIENT'S HOSPITAL STAY WAS EXTENDED. NO ADDITIONAL INFORMATION WAS PROVIDED CONCERNING THE PATIENT'S CONDITION AND CARE.

    Description of Event or Problem · 0

    IT WAS REPORTED, THE CATHETER COULD NOT BE PASSED THROUGH THE END TIP AS THE HOLE WAS TOO NARROW FOR THE CATHETER. THE PATIENT WHO WAS UNSTABLE AT THE TIME, REMAINED ON VENTILATION AS A NEW ATTEMPT WAS MADE WITH A DIFFERENT CLOSED SUCTION CATHETER (CSC). THE QUICK ACTIONS OF THE STAFF ENABLED THE PATIENT TO BE SUCCESSFULLY SUCTIONED AFTER WHICH THE PATIENT FELT BETTER. THE PATIENT'S HOSPITAL STAY WAS EXTENDED. NO ADDITIONAL INFORMATION WAS PROVIDED CONCERNING THE PATIENT'S CONDITION AND CARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    855795 BALLARD CLOSED SUCTION SYSTEM BALLARD CLOSED SUCTION CATHETER, Y-ADAPTER, NEONATAL/PEDIATRIC BSY AVANOS MEDICAL INC. 98383 30324932 00609038983837

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other