BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BALLARD CLOSED SUCTION SYSTEM

    MDR report key: 22155469 · Received June 5, 2025

    Report

    Report Number
    8030647-2025-00053
    Event Type
    Injury
    Date Received
    June 5, 2025
    Date of Event
    May 30, 2025
    Report Date
    September 16, 2025
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    BSY
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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 NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. THE DOCUMENTED UDI IS BASED ON THE STOCK/PRODUCT CODE PROVIDED BY THE REPORTER; THE UDI-PI IS NOT AVAILABLE AS NO LOT NUMBER WAS PROVIDED. ALL INFORMATION REASONABLY KNOWN AS OF (B)(6) 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 CONCLUSION: 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; HOWEVER, THE ROOT CAUSE COULD NOT BE DETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD IS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. THE DOCUMENTED UDI IS BASED ON THE STOCK/PRODUCT CODE PROVIDED BY THE REPORTER; THE UDI-PI IS NOT AVAILABLE AS NO LOT NUMBER WAS PROVIDED. ALL INFORMATION REASONABLY KNOWN AS OF 16 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 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 Y-CONNECTOR (WYE) OF THE ENDOTRACHEAL TUBE (ETT) WAS FOUND TO BE CRACKED AND WORSENING, AT THE END CONNECTING TO THE TUBE, ALONG THE FACTORY INDENTATION IN THE WYE. WHILE DISCONNECTING THE WYE FROM THE TUBE TO REPLACE, THE WYE COMPLETELY SPLIT ALONG THE INDENTATION. THE TUBE WAS QUICKLY CUT IN ORDER TO REMOVE THE LEFTOVER PIECE OF WYE THAT REMAINED LODGED WITHIN THE END OF THE ETT, SO THAT A NEW WYE COULD BE INSERTED. IN THIS TIME THE PATIENT BECAME BRADYCARDIC WITHOUT VENTILATION BUT QUICKLY RECOVERED AFTER RESOLUTION OF EQUIPMENT ISSUE. THE BROKEN WYE WAS IN PLACE FROM TIME OF ETT INSERTION ON (B)(6) 2025 UNTIL IT BROKE ON (B)(6) 2025.

    Description of Event or Problem · 0

    IT WAS REPORTED, THE Y-CONNECTOR (WYE) OF THE ENDOTRACHEAL TUBE (ETT) WAS FOUND TO BE CRACKED AND WORSENING, AT THE END CONNECTING TO THE TUBE, ALONG THE FACTORY INDENTATION IN THE WYE. WHILE DISCONNECTING THE WYE FROM THE TUBE TO REPLACE, THE WYE COMPLETELY SPLIT ALONG THE INDENTATION. THE TUBE WAS QUICKLY CUT IN ORDER TO REMOVE THE LEFTOVER PIECE OF WYE THAT REMAINED LODGED WITHIN THE END OF THE ETT, SO THAT A NEW WYE COULD BE INSERTED. IN THIS TIME THE PATIENT BECAME BRADYCARDIC WITHOUT VENTILATION BUT QUICKLY RECOVERED AFTER RESOLUTION OF EQUIPMENT ISSUE. THE BROKEN WYE WAS IN PLACE FROM TIME OF ETT INSERTION ON (B)(6) 2025 UNTIL IT BROKE ON (B)(6) 2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1461626 BALLARD CLOSED SUCTION SYSTEM BALLARD CLOSED SUCTION CATHETER, NN PED Y ADTR NDEHP,7FR,20 BSY AVANOS MEDICAL INC. 93825 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female