BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAKRI TAMPONADE BALLOON CATHETER

    MDR report key: 1940327 · Received December 17, 2010

    Report

    Report Number
    1825146-2010-00056
    Event Type
    Injury
    Date Received
    December 17, 2010
    Date of Event
    November 6, 2010
    Report Date
    December 10, 2010
    Manufacturer
    COOK UROLOGICAL, INC.
    Product Code
    KNA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN DISCARDED BY THE FACILITY AND WILL NOT BE RETURNED FOR EVALUATION. MOST LIKELY THE STOPCOCK (VALVE) USED TO OPEN AND CLOSE FOR KEEPING FLUIDS INSIDE THE BALLOON HAS SEPARATED. THE PHYSICIAN WAS ABLE TO PUT THE PARTS BACK TOGETHER NOTING THE BALLOON REMAINED INFLATED. HOWEVER, THE BAKRI BALLOON WAS REMOVED FROM THE PT DUE TO THE HEMORRHAGING DID NOT STOP AND A HYSTERECTOMY WAS PERFORMED. THE ATTENDING NURSE STATED THE HYSTERECTOMY WAS NOT DUE TO THE BALLOON. ADDITIONAL INFO IS BEING REQUESTED ON THE EVENTS OF THE CASE TO DETERMINE THE NEED FOR THE HYSTERECTOMY. WHEN ADDITIONAL INFO IS RECEIVED, IT WILL BE FORWARDED.

    Description of Event or Problem · 1

    THE WHITE STOPCOCK VALVE MALFUNCTIONED ON THE PRODUCT AND CAME OUT OF THE PORT. THE PHYSICIAN PUT IT BACK IN PLACE, AND CONTINUED TO USE THE DEVICE, BUT KEPT FLUID IN THE BALLOON. HOWEVER, THEY WERE NOT ABLE TO STOP THE HEMORRHAGING AND REMOVED OUR DEVICE. A HYSTERECTOMY WAS REQUIRED; BUT, NOT DUE TO OUR BALLOON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BAKRI TAMPONADE BALLOON CATHETER KNA INSTRUMENTS, MANUAL, SPECIALIZED, OBSTETRIC-GYNECOLOGIC KNA COOK UROLOGICAL, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1