BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERAL DEVICE DECLOGGING SYSTEM

    MDR report key: 22579525 · Received July 23, 2025

    Report

    Report Number
    2026095-2025-00019
    Event Type
    Injury
    Date Received
    July 23, 2025
    Report Date
    July 23, 2025
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KNT
    UDI-DI
    00350770456096
    PMA / PMN Number
    K970178
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H6 COMPONENT CODE: SOLUTION. THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD IS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED; THEREFORE, THE UDI-PI IS UNAVAILABLE. THE LOT NUMBER WAS NOT PROVIDED BY THE CUSTOMER. ROOT CAUSE COULD NOT BE DETERMINED. ALL INFORMATION REASONABLY KNOWN AS OF 23-JUL-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 AVANOS MEDICAL, INC. 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 AVANOS MEDICAL, INC. AVANOS MEDICAL, INC. 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 AVANOS MEDICAL, INC. 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 AVANOS MEDICAL, INC. PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY.

    Description of Event or Problem · 0

    IT WAS REPORTED A NURSE HAVING SOME SPLASH IN HER EYE FROM THE CLOG ZAPPER SOLUTION. ADDITIONAL INFORMATION RECEIVED 30-JUN-2025 THE NURSE ATTENDED THE EMERGENCY DEPARTMENT (ED) ON ADVICE FROM THE POISONS INFORMATION CENTRE. THE ADVICE WAS TO GO TO ED AND GET TRIAGED. THE TRAUMA PROVIDER DID A LITMUS TEST WHICH BROUGHT AN ABNORMAL READING. THE TREATMENT IN ED INVOLVED A "LOCAL ANESTHETIC TO BOTH EYES AND AN OSMOTIC IRRIGATION SOLUTION TO DRAW OUT ANY CHEMICALS IN THE EYES UNTIL THE LITMUS READING IS ACCEPTABLE. THEN EYES EXAMINED FOR DAMAGE PLUS FOLLOW-UP APPOINTMENT IN OUTPATIENTS. "THE NURSE WAS WEARING GLASSES BUT WAS LOOKING DOWN WHILE READING THE INSTRUCTIONS TO A SECOND NURSE DOING THE PROCEDURE AND THE SOLUTION SPRAYED INTO THE EYES." NO INJURY WAS SUSTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    915145 ENTERAL DEVICE DECLOGGING SYSTEM DH CPK CLOG ZAPPER ACCESSORIES KNT AVANOS MEDICAL INC. 20-0002 UNKNOWN 00350770456096

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Female Required Intervention