BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ON-Q EXPANSION KITS WITH SILVERSOAKER CATHETER 10IN(25 CM)

    MDR report key: 25156662 · Received May 12, 2026

    Report

    Report Number
    2026095-2026-00038
    Event Type
    Malfunction
    Date Received
    May 12, 2026
    Date of Event
    May 1, 2025
    Report Date
    May 12, 2026
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    BSO
    UDI-DI
    00193494135393
    PMA / PMN Number
    K051401
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD FOR THE REPORTED LOT NUMBER, 30311250, IN THIS COMPLAINT WAS REVIEWED AND THE MATERIAL WAS PRODUCED ACCORDING TO THE MANUFACTURING PROCEDURES AND MET THE QUALITY REQUIREMENTS. ALL INFORMATION REASONABLY KNOWN AS OF 12-MAY-2026 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 VIA FDA MEDWATCH / FDA USER FACILITY REPORT MW REPORT 22885309 THE FOLLOWING: RN OPENED AVANOS ON-Q ANTIMICROBIAL EXPANSION KIT TO STERILE BACK TABLE. RN HOLDING KIT OPEN FOR SCRUB TECH TO GRAB SUPPLIES. ANOTHER RN REPORTED HEARING "POP" SOUND AND THE SHEATHED INTRODUCER IN PACKAGE SLING-SHOTTED OUT OF PACKAGE INTO THE FIRST RN'S EYE. RN USED EYEWASH STATION AND EXAMINED EYE. MILD PAIN PRESENT BUT NO OTHER INJURIES NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225924 ON-Q EXPANSION KITS WITH SILVERSOAKER CATHETER 10IN(25 CM) CATHETERS BSO AVANOS MEDICAL INC. PM040-A 30311250 00193494135393

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown