BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TYSHAK II

    MDR report key: 10349511 · Received July 31, 2020

    Report

    Report Number
    10349511
    Event Type
    Malfunction
    Date Received
    July 31, 2020
    Date of Event
    July 10, 2020
    Report Date
    July 14, 2020
    Manufacturer
    B BRAUN INTERVENTIONAL SYSTEMS, INC
    Product Code
    DQY
    UDI-DI
    04046964339417
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    BALLOON BEING PREPPED BEFORE ENTERING THE BODY. BALLOON POPPED DURING PREP TIME WITHOUT FULL AMOUNT OF LIQUID IN BALLOON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    816161 TYSHAK II CATHETER, PERCUTANEOUS DQY B BRAUN INTERVENTIONAL SYSTEMS, INC 611940 TT-15678 04046964339417

    Patients

    Seq Age Sex Outcome Treatment
    1