BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BAKRI TAMPONADE BALLOON CATHETER

    MDR report key: 2033576 · Received February 9, 2011

    Report

    Report Number
    1825146-2011-00010
    Event Type
    Malfunction
    Date Received
    February 9, 2011
    Date of Event
    January 7, 2011
    Report Date
    February 8, 2011
    Manufacturer
    COOK UROLOGICAL INC
    Product Code
    KNA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS IN CONJUNCTION WITH MDR REPORT # 1825146 2011 00010. THE CUSTOMER USED TWO DEVICES IN THE SAME PROCEDURE AND EXPERIENCE THE SAME RESULT WITH BOTH DEVICES, HOWEVER, ONLY ONE OF THE TWO USED DEVICES WERE RETURNED FOR EVALUATION. WITH ONLY ONE DEVICE BEING RETURNED, SEE MDR REPORT 1825146-2011-00011 FOR THE EVALUATION OF USED DEVICE. MOST LIKELY THE STOPCOCK HAS BEEN OVERRIDDEN PAST THE SOLID STOP VIOLATING THE PLUG. BY THE END USER TURNING THE PLUG PORTION PAST THE SOLID STOP, THE PLUG HAS PUSHED OUT AND COME OUT OF THE STOPCOCK BODY CAUSING THE DIFFICULTY THE CUSTOMER EXPERIENCED. THE UNOPENED PACKAGES WERE OPENED NOTING THE STOPCOCKS FUNCTIONED AS INTENDED.

    Description of Event or Problem · 1

    THE STOPCOCK DISLODGED ON THE BAKRI TAMPONADE BALLOON CATHETER, ALLOWING THE CONTENTS OF THE BALLOON TO DISCHARGE. THE BALLOON HAD BEEN INFLATED WITH 420 MIS FLUID AND THE STOPCOCK WAS IN THE CLOSED POSITION. THE BALLOON WAS REMOVED AND A NEW BALLOON PLACED (OF A DIFFERENT LOT). THE EVENT OCCURRED A SECOND TIME. THE STOPCOCK ON THIS BAKRI WAS REPOSITIONED AND ANCHORED WITH MEDICAL TAPE THE SECOND TIME ALLOWING COMPLETION OF THE PROCEDURE. POSTPARTUM HEMORRHAGE. THE PATIENT REPREHENDED EXCESSIVE BLOOD LOSS; HOWEVER, THERE ARE NO REPORTS OF ADDITIONAL PROCEDURES OCCURRING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BAKRI TAMPONADE BALLOON CATHETER KNA INSTRUMENT, MANUAL, SPECIALIZED, OBSTETRIC-GYNECOLOGIC KNA COOK UROLOGICAL INC NA U1988199

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR