BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOK BAKRI POSTPARTUM BALLOON WITH RAPID INSTILLATION COMPONENTS

    MDR report key: 8060679 · Received November 12, 2018

    Report

    Report Number
    1820334-2018-03381
    Event Type
    Malfunction
    Date Received
    November 12, 2018
    Date of Event
    September 20, 2018
    Report Date
    December 6, 2018
    Manufacturer
    COOK INC
    Product Code
    OQY
    UDI-DI
    10827002242378
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: EVENT, CONCOMITANT MEDICAL PRODUCTS. EC RESULTS CODE: 4247 ¿ PINHOLE LEAK ¿ SOURCE UNDETERMINED. INVESTIGATION/EVALUATION: A VISUAL INSPECTION AND FUNCTIONAL TESTING OF THE RETURNED DEVICE WAS CONDUCTED. A DOCUMENT BASED INVESTIGATION WAS ALSO PERFORMED INCLUDING A REVIEW OF COMPLAINT HISTORY, THE DEVICE HISTORY RECORD, DRAWINGS, INSTRUCTIONS FOR USE, MANUFACTURING INSTRUCTIONS, QUALITY CONTROL DATA, SPECIFICATIONS, AND TRENDS. ONE BALLOON CATHETER WAS RETURNED. THE DEVICE HAS BEEN USED AND IS COVERED IN BLOOD. RETURNED PACKAGING CONFIRMS LOT NUMBER: 7692350. FUNCTIONAL TESTING WAS PERFORMED USING WATER AND A SYRINGE. TESTING DETERMINED THERE IS A LEAK IN THE DEVICE. VISUAL EXAMINATION NOTED A PIN HOLE LEAK IN THE BALLOON MATERIAL. A REVIEW OF THE DEVICE HISTORY RECORD FOUND THERE WERE NO NON-CONFORMANCES RELATED TO THE REPORTED FAILURE. A REVIEW OF COMPLAINT HISTORY RECORDS REVEALED THIS IS THE ONLY COMPLAINT ASSOCIATED WITH THE COMPLAINT DEVICE LOT NUMBER: 7692350. THE INSTRUCTIONS FOR USE (IFU) CONTAINS THE PROPER WARNINGS, PRECAUTIONS, AND INSTRUCTIONS FOR USE. A REVIEW OF RELEVANT MANUFACTURING DOCUMENTS WAS CONDUCTED. IT WAS CONCLUDED THAT THE DEVICE ASPECT IN QUESTION WAS VISUALLY/FUNCTIONALLY INSPECTED BY QUALITY CONTROL AND NO RELATED GAPS IN PRODUCTION OR PROCESSING CONTROLS WERE NOTED. IT WAS NOT POSSIBLE TO DETERMINE THE CAUSE FOR THE REPORTED ISSUE. 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. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Description of Event or Problem · 0

    ON (B)(6) 2018, THE CUSTOMER ADVISED THE BALLOON WAS INFLATED WITH SALINE.

    Additional Manufacturer Narrative · 1

    PMA/510(K) #: K170622. (B)(4). 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 INITIALLY REPORTED THE BAKRI BALLOON WOULD NOT HOLD PRESSURE, LEAKING OUT OF THE BALLOON. ADDITIONAL INFORMATION WAS PROVIDED ON 09-NOV-2018 IN RESPONSE TO REQUEST FOR FURTHER DETAILS. THE BAKRI BALLOON WAS USED TO TREAT PATIENT WITH POST PARTUM HEMORRHAGE. THE DEVICE WAS INFLATED TO A MINIMUM OF 120CC USING A 60CC SYRINGE. THE NURSES SAID IT WAS LEAKING. ANOTHER BAKRI BALLOON WAS USED TO COMPLETE THE PROCEDURE. THE REPORTER ADVISED THEY WERE NOT AWARE OF ANY HARM TO THE PATIENT AND THERE WAS NO UNINTENDED SECTION OF THE DEVICE THAT REMAINED INSIDE THE PATIENTS BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    898453 COOK BAKRI POSTPARTUM BALLOON WITH RAPID INSTILLATION COMPONENTS OQY INTRAUTERINE BALLOON OQY COOK INC 7692350 10827002242378

    Patients

    Seq Age Sex Outcome Treatment
    1