BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUET EXTERNAL DRAINAGE

    MDR report key: 23582408 · Received November 18, 2025

    Report

    Report Number
    MW5178962
    Event Type
    Malfunction
    Date Received
    November 18, 2025
    Date of Event
    November 7, 2025
    Report Date
    November 13, 2025
    Manufacturer
    MEDTRONIC MEXICO S. DE R.L. DE CV
    Product Code
    PCB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    (B)(6). THE EMERGENCY DEPARTMENT HAS IN CIRCULATION A RECALLED ITEM BY THE FDA. MEDTRONIC DUET EXTERNAL DRAINAGE AND MONITORING SYSTEM. REFERENCE NUMBER 46913, EXPIRATION DATE 2028-03-07. CLASS ONE DEVICE RECALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2317123 DUET EXTERNAL DRAINAGE EXTERNAL CEREBROSPINAL FLUID (CSF) DIVERSION PCB MEDTRONIC MEXICO S. DE R.L. DE CV 230851850

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other