BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOK BAKRI POSTPARTUM BALLOON WITH RAPID INSTILLATION COMPONENTS

    MDR report key: 8487496 · Received April 5, 2019

    Report

    Report Number
    1820334-2019-00772
    Event Type
    Malfunction
    Date Received
    April 5, 2019
    Date of Event
    March 25, 2019
    Report Date
    June 28, 2019
    Manufacturer
    COOK INC
    Product Code
    OQY
    UDI-DI
    10827002242378
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    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, DEVICE HISTORY RECORD, THE INSTRUCTIONS FOR USE,QUALITY CONTROL DATA, AND TRENDS. THE COMPLAINANT RETURNED ONE J-SOSR-100500 BAKRI BALLOON CATHETER FOR INVESTIGATION. LOT NUMBER OF RETURNED DEVICE CONFIRMS CUSTOMER REPORT OF LOT NUMBER. A VISUAL EXAMINATION OF THE DEVICE CONFIRMED THE FAST-500 RAPID INSTILLATION COMPONENTS WERE RETURNED. THERE WAS NO PHYSICAL DAMAGE VISIBLE ON THE DEVICE. A FUNCTION TEST WAS PERFORMED BY INJECTING WATER INTO THE BALLOON INFLATION LINE, THE BALLOON DID NOT INFLATE. WATER LEAKED FROM THE DRAINAGE PORTS ABOVE THE BALLOON. A REVIEW OF THE DEVICE HISTORY RECORD FOUND THERE WERE 2 NON-CONFORMANCES FOR THIS LOT. COOK WAS UNABLE TO DETERMINE IF THESE ISSUES ARE RELATED TO THIS INCIDENT. A REVIEW OF COMPLAINT HISTORY RECORDS REVEALED THERE HAS BEEN ONE OTHER COMPLAINTS ASSOCIATED WITH THE COMPLAINT DEVICE LOT NUMBER INVOLVING ONE UNIT AND A REPORTED LEAK. THE INSTRUCTIONS FOR USE(IFU) PROVIDES THE FOLLOWING INFORMATION TO THE USER RELATED TO THE REPORTED FAILURE MODE: WARNINGS "THE BALLOON SHOULD BE INFLATED WITH STERILE LIQUID SUCH AS STERILE WATER, STERILE SALINE, OR LACTATED RINGERS SOLUTION. THE BALLOON SHOULD NEVER BE INFLATED WITH AIR, CARBON DIOXIDE OR ANY OTHER GAS." HOW SUPPLIED "UPON REMOVAL FROM THE PACKAGE, INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED." A REVIEW OF RELEVANT MANUFACTURING DOCUMENTS WAS CONDUCTED. IT WAS CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. BALLOONS ARE LEAK TESTED 100% BY THE SUPPLIER. DURING INCOMING INSPECTION PROCEDURE, IT IS REQUIRED TO ASSURE CERTIFICATE OF COMPLIANCE. ASSURE LOT NUMBERS MATCH. THE CERTIFICATE IS SIGNED AND SHOWS 100% LEAK TESTING STATEMENT. A DEFINITIVE CONCLUSION COULD NOT BE DETERMINED. THE MOST PROBABLE CAUSE OF LEAKAGE HAS BEEN CONTRIBUTED TO LUMEN COMMUNICATION. A DEFINITIVE CAUSE OF THE LUMEN COMMUNICATION COULD NOT BE DETERMINED. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS WARRANTED. 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

    NO ADDITIONAL EVENT INFORMATION TO REPORT.

    Additional Manufacturer Narrative · 1

    (B)(6). OCCUPATION: DISTRIBUTOR¿S AGENT. 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 REPORTED DURING TREATMENT FOR POSTPARTUM HEMORRHAGE, THE DOCTOR INFLATED THE BALLOON TO TEST THE PRODUCT INTEGRITY AND FOUND LIQUID LEAKING FROM SIDE PORT. THIS OCCURRED PRIOR TO PATIENT CONTACT. ADDITIONAL INFORMATION WAS PROVIDED ON 02APR2019. THE BLOOD LOSS WAS NOT VERY SERIOUS, SO THE PATIENT CAME TO HEMOSTASIS NATURALLY. NO ADVERSE EFFECTS TO THE PATIENT WERE EXPERIENCED. THE PATIENT RECOVERED WELL. THE DOCTOR WILL NOT PROVIDE ANY OTHER PATIENT INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280262 COOK BAKRI POSTPARTUM BALLOON WITH RAPID INSTILLATION COMPONENTS OQY INTRAUTERINE BALLOON OQY COOK INC G24237 9073957 10827002242378

    Patients

    Seq Age Sex Outcome Treatment
    1