BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRESENT CATHETER CANNULA 32 FR

    MDR report key: 20611358 · Received November 4, 2024

    Report

    Report Number
    MW5162166
    Event Type
    Malfunction
    Date Received
    November 4, 2024
    Date of Event
    October 30, 2024
    Report Date
    October 31, 2024
    Manufacturer
    MC3, INC.
    Product Code
    PZS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    CRESCENT CANNULA USED THIS AFTERNOON ON AN ADULT SIZED ADOLESCENT. THE SURGEON HAD DIFFICULTY WITH INSERTION. 32 F CRESCENT WAS ATTEMPTED, LOT NUMBER 2203215 (03/31/2025). WE DID SAVE THE CANNULA TO RETURN TO THE VENDOR. THE VENDOR WAS CONTACTED. NO PATIENT COMPROMISES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2132306 CRESENT CATHETER CANNULA 32 FR DUAL LUMEN ECMO CANNULA PZS MC3, INC. 70132 2203215

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Male