BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROPUNCTURE INTRODUCER SET

    MDR report key: 22545792 · Received July 18, 2025

    Report

    Report Number
    MW5172951
    Event Type
    Malfunction
    Date Received
    July 18, 2025
    Date of Event
    July 16, 2025
    Report Date
    July 16, 2025
    Manufacturer
    COOK MEDICAL LLC.
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    WIRE FROM COOK MICROPUNCTURE INTRODUCER SET (REF MPIS-401-10.0-SC-SST) OPENED FOR CASE, NOT ENTERED INTO BODY. NOTED DISTAL WIRE END HAD UNRAVELED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2784675 MICROPUNCTURE INTRODUCER SET INTRODUCER, CATHETER DYB COOK MEDICAL LLC. 16624376

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown