BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BAKRI TAMPONADE BALLOON CATHETER

    MDR report key: 7512096 · Received May 14, 2018

    Report

    Report Number
    1820334-2018-01502
    Event Type
    Malfunction
    Date Received
    May 14, 2018
    Date of Event
    April 27, 2018
    Report Date
    July 27, 2018
    Manufacturer
    COOK INC
    Product Code
    OQY
    UDI-DI
    10827002306735
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). 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. THE DEVICE WAS RETURNED WET. A FUNCTIONAL TEST WAS PERFORMED. IT WAS DETERMINED THAT THERE IS A LUMEN COMMUNICATION BETWEEN THE TWO LUMENS. WHEN INFLATING THE BALLOON LUMEN WITH WATER, IT WAS NOTED THAT WATER WAS FILTERING THROUGH THE SIDE PORT AND BACKEND OF THE OTHER LUMEN. THE DEVICE HISTORY RECORD WAS REVIEWED AND NOTED THERE WERE NO NON-CONFORMANCES ASSOCIATED WITH THE REPORTED FAILURE. A REVIEW OF COMPLAINT HISTORY REVEALED THIS COMPLAINT IS THE ONLY ONE ASSOCIATED WITH COMPLAINT LOT NUMBER 8278903. 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. NO CONCLUSION COULD BE DRAWN AS TO THE CAUSE FOR THE CONFIRMED BALLOON INFLATION ISSUE. COOK MEDICAL HAS NOTIFIED THE APPROPRIATE PERSONNEL AND WILL CONTINUE TO MONITOR THIS DEVICE VIA THE COMPLAINTS DATABASE FOR SIMILAR COMPLAINTS.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN THE USER CHECKED THE BAKRI TAMPONADE BALLOON CATHETER FUNCTION PRIOR TO PATIENT CONTACT THE BALLOON WOULD NOT INFLATE. THERE WAS NO PATIENT CONTACT WITH THE DEVICE.

    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 WHEN THE USER CHECKED THE BAKRI TAMPONADE BALLOON CATHETER FUNCTION PRIOR TO PATIENT CONTACT THE BALLOON WOULD NOT INFLATE. THERE WAS NO PATIENT CONTACT WITH THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355077 BAKRI TAMPONADE BALLOON CATHETER OQY INTRAUTERINE BALLOON OQY COOK INC 8278903 10827002306735

    Patients

    Seq Age Sex Outcome Treatment
    1