BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BALLARD CLOSED SUCTION SYSTEM

    MDR report key: 21540215 · Received March 6, 2025

    Report

    Report Number
    8030647-2025-00022
    Event Type
    Malfunction
    Date Received
    March 6, 2025
    Date of Event
    February 6, 2025
    Report Date
    June 10, 2025
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    BSY
    UDI-DI
    00609038938240
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    117

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: D1. ADDITIONAL INFORMATION: H6 THE PRODUCT INVOLVED IN THE REPORT HAS NOT BEEN RETURNED FOR EVALUATION; HOWEVER, THE REPORTER PROVIDED PHOTOGRAPHIC /VIDEO EVIDENCE WHICH DEPICTS THE REPORTED EVENT: BROKEN Y-ADAPTOR; THE COMPLAINT IS CONSIDERED TO BE CONFIRMED. INVESTIGATION FOR THIS FAILURE MODE WAS PREVIOUSLY PERFORMED; AS THE ISSUE IS A KNOWN FAILURE; THE ROOT CAUSE WAS DETERMINED TO BE MANUFACTURING RELATED. PROCESSES ARE IN PLACE TO PREVENT FUTURE REOCCURRENCE OF THE ISSUE. THE DEVICE HISTORY RECORD FOR LOT 4301085 WAS REVIEWED AND THE PRODUCT WAS PRODUCED ACCORDING TO PRODUCT SPECIFICATIONS. ALL INFORMATION REASONABLY KNOWN AS OF 10 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 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

    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 06 MAR 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 COMPLAINT-(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, THE BALLARD IN-LINE SUCTION SNAPPED OFF WITH THE SPIKE BEING STUCK IN THE OPENING OF THE 3.0 ENDOTRACHEAL TUBE (ETT), THIS MADE IT IMPOSSIBLE TO BAG THE PATIENT. THE RESPIRATORY THERAPIST (RT) CUT THE ETT AND INSERT A NEW BALLARD IN ORDER TO BAG THE PATIENT; THERE WAS NO PATIENT HARM.

    Description of Event or Problem · 0

    IT WAS REPORTED, THE BALLARD IN-LINE SUCTION SNAPPED OFF WITH THE SPIKE BEING STUCK IN THE OPENING OF THE 3.0 ENDOTRACHEAL TUBE (ETT), THIS MADE IT IMPOSSIBLE TO BAG THE PATIENT. THE RESPIRATORY THERAPIST (RT) CUT THE ETT AND INSERT A NEW BALLARD IN ORDER TO BAG THE PATIENT; THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    436329 BALLARD CLOSED SUCTION SYSTEM BALLARD CLOSED SUCTION CATHETER, Y-ADAPTER, NEONATAL/PEDIATRIC BSY AVANOS MEDICAL INC. 93824 4301085 00609038938240

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown