BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GEL ULTRASOUND PREMIUM 8 OUNCE NON-STERILE

    MDR report key: 21814618 · Received April 10, 2025

    Report

    Report Number
    3003753847-2025-00009
    Event Type
    Injury
    Date Received
    April 10, 2025
    Date of Event
    August 9, 2024
    Report Date
    April 30, 2025
    Manufacturer
    OWENS & MINOR DISTRIBUTION, INC.
    Product Code
    IYO
    PMA / PMN Number
    K883917
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INCIDENT EIGHT OF TEN. THE PRODUCT INVOLVED IN THIS EVENT IS NOT AVAILABLE FOR EVALUATION. OWENS & MINOR DISTRIBUTION, INC. IS THE INITIAL IMPORTER AND DISTRIBUTOR OF THE MEDICAL DEVICE. THE PRODUCT IS SUPPLIED BY MAC MEDICAL SUPPLY COMPANY, INC. (FDA REGISTRATION NUMBER 3004963952). THE MANUFACTURER OF THE PRODUCT IS NEXT MEDICAL PRODUCTS COMPANY (FDA REGISTRATION NUMBER 2523891). A SCAR (SUPPLIER CORRECTIVE ACTION REQUEST) WAS ISSUED ON MARCH 20, 2025. A FOLLOW-UP REPORT WILL BE PROVIDED UPON CONCLUSION OF INVESTIGATION. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE 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 PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY.

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER HAS COMPLETED SUPPLIER CORRECTIVE ACTION REQUEST. THE DEVICE HISTORY RECORD WAS REVIEWED. THERE WERE NO ISSUES DOCUMENTED DURING THE PRODUCTION PROCESS OF THIS PRODUCT. THIS LOT WAS PRODUCED WITHIN SPECIFICATION REQUIREMENTS. THE BACTERIA REPORTED IS COMMONLY FOUND THROUGHOUT NATURE AND IS BEING ADDED TO PRODUCE IN THE AGRICULTURAL INDUSTRY AS A NATURAL, ORGANIC WAY TO BOOST GROWTH. THEREFORE, IT IS HEAVILY FOUND IN RUNOFF AND WATER SUPPLY ACCORDING TO MANUFACTURER. THE MANUFACTURER HAS COLLABORATED WITH A LAB TO DEVELOP A TEST FOR PARABURKHOLDERIA IN ULTRASOUND GEL. THE MANUFACTURER IMPLEMENTED CHANGES TO WATER SYSTEM, ADDING UV FILTRATION. THE MANUFACTURER HAS CHANGED PRESERVATIVE IN ULTRASOUND GEL TO ONE THAT ACTIVELY KILLS PARABURKHOLDERIA UPON CONTACT.

    Description of Event or Problem · 0

    THE (B)(6) DEPARTMENT OF HEALTH NOTIFIED ALLINA INFECTION PREVENTION THERE WERE 10 ALLINA PATIENTS IDENTIFIED WITH CONTAMINATED BLOOD CULTURES. THE MEDICHOICE BRANDED ULTRASOUND GEL WAS UTILIZED ON PATIENTS. (B)(6) HEALTH DEPARTMENT REQUESTED SAMPLES FROM ALLINA OF THE GEL. SAMPLE OF MEDICHOICE PREMIUM ULTRASOUND GEL, REF. 10080212 (LOT. 240302) IS THE ONLY ONE THAT TESTED POSITIVE FOR PARABURKHOLDERIA. THE ULTRASOUND GEL IS BRANDED NONSTERILE. THE PATIENT WAS RE ADMITTED TO THE HOSPITAL SPECIFICALLY FOR ANTIBIOTIC TREATMENT AS A RESULT OF P. FUNGORM ISOLATED FROM BLOOD CULTURE. THE BLOOD CULTURE WAS COLLECTED IN THE ALLINA EMERGENCY DEPARTMENT. THERE WAS AN ULTRASOUND GUIDED PIV PLACED IN THE EMERGENCY DEPARTMENT BEFORE THE BLOOD CULTURE WAS COLLECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1816617 GEL ULTRASOUND PREMIUM 8 OUNCE NON-STERILE ULTRASOUND GEL IYO OWENS & MINOR DISTRIBUTION, INC. 10080212 240302

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other