BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXOR CHECK-FLO INTRODUCER

    MDR report key: 21798099 · Received April 8, 2025

    Report

    Report Number
    MW5168712
    Event Type
    Malfunction
    Date Received
    April 8, 2025
    Date of Event
    April 1, 2025
    Report Date
    April 3, 2025
    Manufacturer
    COOK MEDICAL LLC
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    SHEATH DEFECTIVE, HUB BROKE MID CASE UPON PULLING JETSTREAM CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1455084 FLEXOR CHECK-FLO INTRODUCER INTRODUCER, CATHETER DYB COOK MEDICAL LLC 16455724

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female