BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEERABLE INTRODUCER SHEATH 8.5F MEDIUM CURL

    MDR report key: 21872866 · Received April 21, 2025

    Report

    Report Number
    21872866
    Event Type
    Malfunction
    Date Received
    April 21, 2025
    Date of Event
    March 17, 2025
    Report Date
    April 15, 2025
    Manufacturer
    FREUDENBERG MEDICAL, LLC
    Product Code
    DYB
    UDI-DI
    00850004312025
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    CATHETER RESISTANCE WHEN INSERTED INTO STRYKER SHEATH WHILE IN BODY. DEVICE REMOVED AND COLLECTED. NEW SHEATH ACQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1338881 STEERABLE INTRODUCER SHEATH 8.5F MEDIUM CURL INTRODUCER, CATHETER DYB FREUDENBERG MEDICAL, LLC SS085075M 0000257411 00850004312025

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Female