BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BALLARD 24-HOUR ORAL CARE KIT

    MDR report key: 22758270 · Received August 8, 2025

    Report

    Report Number
    8030647-2025-00073
    Event Type
    Malfunction
    Date Received
    August 8, 2025
    Date of Event
    July 9, 2025
    Report Date
    October 28, 2025
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    NSB
    UDI-DI
    10609038970216
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: D9 ADDITIONAL INFORMATION-INVESTIGATION COMPLETE: D4; H4; H6. THE PRODUCT INVOLVED IN THE REPORT OF CONTINUOUS SUCTION WAS RETURNED AND PROCESSED FOR EVALUATION. THE DEVICE WAS PHYSICALLY EVALUATED, AND THE SEAL WAS INSPECTED, IT APPEARED TO BE WORKING ALONG THE SWITCH; HOWEVER, AS THE SAMPLE WAS CONTAMINATED FURTHER EVALUATION COULD NOT BE PERFORMED. PHOTOGRAPHS OF THE DEVICE WERE EVALUATED; ANALYSIS OF THE PHOTOGRAPHS, OBSERVED THE VALVE REMAINED SEALED WITH THE BUTTON (SLIDER) IN THE OFF POSITION. HOWEVER, AS THE SAMPLE WAS CONTAMINATED FUNCTIONAL TESTING OF THE VACUUM LOSS IN THE SUCTION VALVE WHILE THE BUTTON (SLIDER) IS IN THE OFF POSITION COULD NOT BE PERFORMED; THEREFORE, IT WAS NOT POSSIBLE TO CONFIRM THE FAILURE MODE. THE DEVICE HISTORY RECORD FOR LOT 1602617 WAS REVIEWED AND THE PRODUCT WAS PRODUCED ACCORDING TO PRODUCT SPECIFICATIONS. ALL INFORMATION REASONABLY KNOWN AS OF 28 OCT 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 08 AUG 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

    THE NURSE REPORTED THE SUCTION WAS STILL ON WHILE THE SWITCH ON THE HANDLE WAS TURNED OFF; DISCOVERED DURING PATIENT USE. THERE WAS NO REPORTED INJURY.

    Description of Event or Problem · 0

    THE NURSE REPORTED THE SUCTION WAS STILL ON WHILE THE SWITCH ON THE HANDLE WAS TURNED OFF; DISCOVERED DURING PATIENT USE. THERE WAS NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2424608 BALLARD 24-HOUR ORAL CARE KIT BALLARD 24-HOUR ORAL CARE KIT NSB AVANOS MEDICAL INC. 97021 1602617 10609038970216

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown