BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BALLARD CLOSED SUCTION SYSTEM

    MDR report key: 21381282 · Received February 13, 2025

    Report

    Report Number
    8030647-2025-00015
    Event Type
    Malfunction
    Date Received
    February 13, 2025
    Date of Event
    December 16, 2024
    Report Date
    February 13, 2025
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    BSY
    UDI-DI
    00609038938264
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 13 FEB 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

    CORRECTION: D8; G1. ADDITIONAL INFORMATION: NA. THE PRODUCT INVOLVED IN THE REPORT WAS NOT RETURNED FOR EVALUATION, ADDITIONALLY, THE REPORTER DID NOT PROVIDE ANY PHOTOS/VIDEOS TO REVIEW; HOWEVER, THE REPORTED FAILURE MODE HAS BEEN PREVIOUSLY INVESTIGATED AND DOCUMENTED. THE ROOT CAUSE WAS DETERMINED TO BE MANUFACTURING RELATED; PROCESSES ARE IN PLACE TO PREVENT THE REPORTED EVENT FROM REOCCURRING. THE DEVICE HISTORY RECORD FOR LOT 30303708 WAS REVIEWED AND THE PRODUCT WAS PRODUCED ACCORDING TO PRODUCT SPECIFICATIONS. ALL INFORMATION REASONABLY KNOWN AS OF 24 JUN 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

    BREAKAGE OF THE 'KEY' OF THE CLOSED SUCTION SYSTEM WAS REPORTED, WHICH RESULTED IN DELAYED ASPIRATION (DUE TO TIME TO OBTAIN A NEW TRACHCARE FROM STOCK AND REPLACE IT ON THE PATIENT'S TUBE. IT WAS ADDITIONALLY REPORTED, THERE WAS NO REPORTED INJURY; HOWEVER, POSSIBLE ALVEOLAR RECRUITMENT IN THE CASE OF MECONIUM ASPIRATION IN THE BABY WAS NOTED.

    Description of Event or Problem · 0

    BREAKAGE OF THE 'KEY' OF THE CLOSED SUCTION SYSTEM WAS REPORTED, WHICH RESULTED IN DELAYED ASPIRATION (DUE TO TIME TO OBTAIN A NEW TRACHCARE FROM STOCK AND REPLACE IT ON THE PATIENT'S TUBE. IT WAS ADDITIONALLY REPORTED, THERE WAS NO REPORTED INJURY; HOWEVER, POSSIBLE ALVEOLAR RECRUITMENT IN THE CASE OF MECONIUM ASPIRATION IN THE BABY WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1460057 BALLARD CLOSED SUCTION SYSTEM BALLARD CLOSED SUCTION CATHETER, Y-ADAPTER, NEONATAL/PEDIATRIC BSY AVANOS MEDICAL INC. 93826 30303708 00609038938264

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown