BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVANOS, BALLARD ORAL CARE

    MDR report key: 21531683 · Received March 5, 2025

    Report

    Report Number
    8030647-2025-00021
    Event Type
    Malfunction
    Date Received
    March 5, 2025
    Date of Event
    February 6, 2025
    Report Date
    August 1, 2025
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    NSB
    UDI-DI
    00609038970219
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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 IN-PROGRESS. ALL INFORMATION REASONABLY KNOWN AS OF 05 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 (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: G1. ADDITIONAL INFORMATION-INVESTIGATION CONCLUSION: D4; H4; H6. THE PRODUCT INVOLVED IN THE REPORT WAS NOT RETURNED FOR EVALUATION, ADDITIONALLY, NO VISUAL EVIDENCE, SUCH AS PHOTOGRAPHS OR VIDEOS WERE PROVIDED; THEREFORE, A ROOT CAUSE COULD NOT BE DETERMINED. THE DEVICE HISTORY RECORD FOR LOT 1562633 WAS REVIEWED AND THE PRODUCT WAS PRODUCED ACCORDING TO PRODUCT SPECIFICATIONS. AS PART OF THE QUALITY CONTROL FOR THE BATCH REPORTED IN THE CUSTOMER COMPLAINT (1562633), 315 UNITS WERE SELECTED AS A REPRESENTATIVE SAMPLE FROM A TOTAL OF (B)(4) UNITS. NO ANOMALIES WERE DETECTED DURING THE QUALITY CONTROL INSPECTION. DURING THE MANUFACTURING OF THE SUBASSEMBLY (SUCTION SWAB) USED FOR PACKAGING PART NUMBER 97021 (BATCH 1562633), A SAMPLE OF 125 UNITS WAS TAKEN FROM A TOTAL OF (B)(4). THE INSPECTION WAS CONDUCTED TO CHECK FOR "MISSING OR UNCONNECTED PARTS" AND "DAMAGE OR BURNS ON THE SPONGE." NO DEFECTS WERE DETECTED. ADDITIONALLY, 20 FORCE TESTS WERE PERFORMED ON THE SPONGE, WITH SATISFACTORY RESULTS. ALL INFORMATION REASONABLY KNOWN AS OF 01 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 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

    WHILE THE CRITICAL CARE NURSE WAS PERFORMING ORAL CARE ON THE PATIENT THE SUCTION SWAB FELL APART IN THE PATIENT'S MOUTH AND THE NURSE HAD TO PHYSICALLY REMOVE THE SPONGE AND GREEN TIP FROM THE PATIENT'S MOUTH. THERE WAS NO PATIENT INJURY; THE ORAL CARE DEVICE WAS REPLACED.

    Description of Event or Problem · 0

    WHILE THE CRITICAL CARE NURSE WAS PERFORMING ORAL CARE ON THE PATIENT THE SUCTION SWAB FELL APART IN THE PATIENT'S MOUTH AND THE NURSE HAD TO PHYSICALLY REMOVE THE SPONGE AND GREEN TIP FROM THE PATIENT'S MOUTH. THERE WAS NO PATIENT INJURY; THE ORAL CARE DEVICE WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    812804 AVANOS, BALLARD ORAL CARE BALLARD ORAL CARE Q4 KIT NSB AVANOS MEDICAL INC. 97021 1562633 00609038970219

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown