BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLAKE

    MDR report key: 22175044 · Received June 10, 2025

    Report

    Report Number
    22175044
    Event Type
    Malfunction
    Date Received
    June 10, 2025
    Date of Event
    June 9, 2025
    Report Date
    June 9, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    GBX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    WHEN A POST-OP PATIENT CAME TO CLINIC TODAY IT WAS FOUND THAT THEIR 15 FRENCH BLAKE DRAIN (CATALOGUE NUMBER 2233) WAS NOT HOLDING SUCTION TO THE JP [JACKSON-PRATT] RESERVOIR (CATALOGUE NUMBER 0070740). ACCORDING TO DR. THIS HAS HAPPENED TO THE PLASTIC SURGEONS OVER 10-15 TIMES WITHIN THE PAST 2-3 WEEKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1632880 BLAKE CATHETER, IRRIGATION GBX ETHICON INC. 2233

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female