BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BALLARD CLOSED SUCTION CATHETER, Y-ADAPTER, NEONATAL/PEDIATRIC

    MDR report key: 21360545 · Received February 11, 2025

    Report

    Report Number
    8030647-2025-00014
    Event Type
    Malfunction
    Date Received
    February 11, 2025
    Date of Event
    November 25, 2024
    Report Date
    May 30, 2025
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    BSY
    UDI-DI
    00609038983837
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: G1. ADDITIONAL INFORMATION: H6. THE ACTUAL COMPLAINT PRODUCT WAS NOT AVAILABLE FOR RETURN. WITHOUT A SAMPLE TO PERFORM FUNCTIONAL EVALUATION OR PHOTOGRAPHIC /VIDEO EVIDENCE THE ROOT CAUSE COULD NOT BE DETERMINED. THE DEVICE HISTORY RECORD FOR LOT 30322240 WAS REVIEWED AND THE PRODUCT WAS PRODUCED ACCORDING TO PRODUCT SPECIFICATIONS ALL INFORMATION REASONABLY KNOWN AS OF 30 MAY 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.

    Additional Manufacturer Narrative · 0

    THE ACTUAL COMPLAINT PRODUCT WAS NOT AVAILABLE FOR RETURN. A REVIEW OF THE DEVICE HISTORY RECORD IS IN-PROGRESS. ALL INFORMATION REASONABLY KNOWN AS OF 11 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.

    Description of Event or Problem · 0

    IT WAS REPORTED; THE CHILD'S CLOSED SUCTION SYSTEM (CSC) WAS CHANGED EVERY MORNING BY IDE. AN ATTEMPT TO FLUSH SALINE THROUGH THE ORIFICE PROVIDED FOR THIS PURPOSE ON THE CLOSED SYSTEM WAS MADE; HOWEVER, THE SUCTION PROBE WAS BLOCKED AT THE Y [CONNECTOR] AND IT WAS IMPOSSIBLE TO SUCTION THE CHILD WHO DESATURATED. THE DECISION TO DECODE AND TO ASPIRATE DIRECTLY INTO THE TRACHEA WITH A STANDARD SUCTION TUBE WAS MADE. THE CSC WAS REPLACED AND THERE WERE NO ADDITIONAL PROBLEMS AFTER THAT.

    Description of Event or Problem · 0

    IT WAS REPORTED, THE CHILD'S CLOSED SUCTION SYSTEM (CSC) WAS CHANGED EVERY MORNING BY IDE. AN ATTEMPT TO FLUSH SALINE THROUGH THE ORIFICE PROVIDED FOR THIS PURPOSE ON THE CLOSED SYSTEM WAS MADE; HOWEVER, THE SUCTION PROBE WAS BLOCKED AT THE Y [CONNECTOR] AND IT WAS IMPOSSIBLE TO SUCTION THE CHILD WHO DESATURATED. THE DECISION TO DECODE AND TO ASPIRATE DIRECTLY INTO THE TRACHEA WITH A STANDARD SUCTION TUBE WAS MADE. THE CSC WAS REPLACED AND THERE WERE NO ADDITIONAL PROBLEMS AFTER THAT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    904787 BALLARD CLOSED SUCTION CATHETER, Y-ADAPTER, NEONATAL/PEDIATRIC CATHETERS, SUCTION, TRACHEOBRONCHIAL BSY AVANOS MEDICAL INC. 98383 30322240 00609038983837

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown