BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BAKRI TAMPONADE BALLOON CATHETER

    MDR report key: 7372893 · Received March 27, 2018

    Report

    Report Number
    1820334-2018-00700
    Event Type
    Malfunction
    Date Received
    March 27, 2018
    Date of Event
    March 2, 2018
    Report Date
    June 14, 2018
    Manufacturer
    COOK INC
    Product Code
    OQY
    UDI-DI
    10827002306735
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION ¿ EVALUATION: A VISUAL INSPECTION AND FUNCTIONAL TESTING OF THE RETURNED DEVICE WAS PERFORMED. THE INVESTIGATION ALSO INCLUDED REVIEW OF COMPLAINT HISTORY, THE DEVICE HISTORY RECORD, DRAWINGS, QUALITY CONTROL DATA, AND SPECIFICATIONS. ONE DEVICE WAS RETURNED FOR INVESTIGATION. A 60-ML SYRINGE WAS RETURNED WITH THE BALLOON CATHETER. A FUNCTIONAL TEST WAS PERFORMED USING THE RETURNED SYRINGE AND A CUT WAS NOTED IN THE BALLOON MATERIAL. THE DEVICE HISTORY RECORD WAS REVIEWED AND NOTED THERE WERE NO NON-CONFORMANCES ASSOCIATED WITH THE COMPLAINT DEVICE LOT NUMBER. A REVIEW OF COMPLAINT HISTORY REVEALED THIS IS THE ONLY COMPLAINT ASSOCIATED WITH THE COMPLAINT DEVICE LOT NUMBER 7701769. A REVIEW OF RELEVANT MANUFACTURING DOCUMENTS WAS CONDUCTED. THIS DEVICE IS 100% INSPECTED VISUALLY FOR SURFACE IMPERFECTIONS AND FUNCTIONALLY TESTED FOR LEAKS, INFLATION, AND DEFLATION. THE DEVICE EVALUATION CONFIRMED A CUT IN THE BALLOON MATERIAL WAS PRESENT RESULTING IN THE OBSERVED LEAK. THE CAUSE OF THE CUT IS UNKNOWN BUT APPEARS TO HAVE OCCURRED DURING HANDLING. MEASURES HAVE BEEN INITIATED TO ADDRESS THIS FAILURE MODE. COOK MEDICAL HAS NOTIFIED THE APPROPRIATE PERSONNEL AND WILL CONTINUE TO MONITOR THIS DEVICE VIA THE COMPLAINTS DATABASE FOR SIMILAR COMPLAINTS.

    Additional Manufacturer Narrative · 1

    (B)(4). PMA/510(K) #: K170622. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE BAKRI TAMPONADE BALLOON CATHETER LEAKED DURING PRE-OP TESTING WHEN FILLED WITH 50ML OF SALINE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT AS A RESULT OF THIS REPORTED ISSUE. THE DEVICE DID NOT MAKE CONTACT WITH THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    219083 BAKRI TAMPONADE BALLOON CATHETER OQY INTRAUTERINE BALLOON OQY COOK INC 10827002306735

    Patients

    Seq Age Sex Outcome Treatment
    1