BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN SILVER SOAKER CATHETER

    MDR report key: 23661040 · Received November 26, 2025

    Report

    Report Number
    2026095-2025-00032
    Event Type
    Malfunction
    Date Received
    November 26, 2025
    Report Date
    May 6, 2026
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    BSO
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE SAMPLE IS REPORTEDLY AVAILABLE FOR THIS COMPLAINT BUT WAS NOT RETURNED WHEN THIS REPORT WAS FILED. 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. ALL INFORMATION REASONABLY KNOWN AS OF 26-NOV-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 THE FAMILY MEMBER STATES THE "CATHETER HAS [FOUR] BLACK MARKINGS, BUT THEY DO NOT SEE A BLACK TIP. [FAMILY MEMBER] THINKS IT IS FINE, BUT IT DOESN'T LOOK LIKE PICTURE ON PAPERWORK. [VIDEO CALL] WITH [FAMILY MEMBER] AND [FOUR] BLACK SKIN MARKINGS ARE VISIBLE ON CATHETER BUT NO BLACK TIP. [FAMILY MEMBER] STATES THAT [PATIENT] REMOVED THE CATHETER AND HAD NO PROBLEMS THAT IT SLID OUT EASILY. [FAMILY MEMBER] TEXTED TWO PICTURES OF CATHETER. IT IS [AN AVANOS] SILVER SOAKER CATHETER. CANNOT SEE BLACK TIP. GUIDED [FAMILY MEMBER] TO CONTACT THE SURGEON AND SEND PICTURES TO GET MEDICAL GUIDANCE." THERE WAS NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301788 UNKNOWN SILVER SOAKER CATHETER CATHETERS BSO AVANOS MEDICAL INC. UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female