BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOK BAKRI POSTPARTUM BALLOON WITH RAPID INSTILLATION COMPONENTS

    MDR report key: 8105961 · Received November 27, 2018

    Report

    Report Number
    1820334-2018-03446
    Event Type
    Malfunction
    Date Received
    November 27, 2018
    Date of Event
    November 2, 2018
    Report Date
    December 6, 2018
    Manufacturer
    COOK INC
    Product Code
    OQY
    UDI-DI
    10827002242378
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNCHANGED, OR UNAVAILABLE. INVESTIGATION ¿ EVALUATION. THE COMPLAINT DEVICE WAS NOT RETURNED FOR AN EVALUATION AND NO PHOTOGRAPH WAS PROVIDED. WITHOUT THE COMPLAINT DEVICE, A DEVICE FAILURE ANALYSIS WAS UNABLE TO BE PERFORMED. A DOCUMENT BASED INVESTIGATION WAS CONDUCTED INCLUDING A REVIEW OF COMPLAINT HISTORY, THE DEVICE HISTORY RECORD, INSTRUCTIONS FOR USE, MANUFACTURING INSTRUCTIONS, AND QUALITY CONTROL DATA. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED ONE NON-CONFORMANCE FOR GLUE INADEQUATE THAT AFFECTED 45 PIECES. A REVIEW OF THE SUB-ASSEMBLY DEVICE HISTORY RECORDS REVEALED NO NON-CONFORMANCES. A REVIEW OF COMPLAINT HISTORY RECORDS REVEALED THIS IS THE ONLY COMPLAINT ASSOCIATED WITH THE COMPLAINT DEVICE LOT NUMBER 9031345. THIS DEVICE IS SHIPPED WITH THE INSTRUCTIONS FOR USE (IFU) WHICH CONTAINS THE FOLLOWING RELEVANT INFORMATION: TO ENSURE THAT THE BALLOON IS FILLED TO THE DESIRED VOLUME, IT IS RECOMMENDED THAT THE PREDETERMINED VOLUME OF FLUID BE PLACED IN A SEPARATE CONTAINER, RATHER THAN RELYING ON A SYRINGE COUNT TO VERIFY THE AMOUNT OF FLUID THAT HAS BEEN INSTILLED INTO THE BALLOON. PRECAUTIONS AVOID EXCESSIVE FORCE WHEN INSERTING THE BALLOON INTO THE UTERUS. WARINING: ALWAYS INFLATE THE BALLOON WITH STERILE LIQUID. NEVER INFLATE WITH AIR, CARBON DIOXIDE OR ANY OTHER GAS. HOW SUPPLIED STORE IN A DARK, DRY, COOL PLACE. AVOID EXTENDED EXPOSURE TO LIGHT. UPON REMOVAL FROM THE PACKAGE, INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED. THE INVESTIGATION FOUND THERE WERE NO OTHER COMPLAINTS RELATED TO THIS LOT NUMBER. A CONCLUSION AS TO THE CAUSE OF THE REPORTED ISSUE COULD NOT BE ESTABLISHED WITH THE AVAILABLE INFORMATION. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO ADDITIONAL RISK MITIGATING ACTIVITY IS REQUIRED AT THIS TIME. 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

    THERE HAS BEEN NO NEW INFORMATION RECEIVED SINCE THE LAST REPORT WAS SUBMITTED.

    Additional Manufacturer Narrative · 1

    PMA/510K # 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, THE COOK BAKRI POSTPARTUM BALLOON WITH RAPID INSTILLATION COMPONENTS WAS USED TO MANAGE A POSTPARTUM HEMORRHAGE (PPH) (UTERINE ATONY). AFTER TRANSVAGINAL PLACEMENT OF THE BAKRI BALLOON AND FILLING IT WITH 500ML STERILE FLUID, THE FLUID IMMEDIATELY RAN OUT OF THE BALLOON. THE FLUID RUNS OUT OF THE VAGINA AND THE DOCTORS CONFIRMED UNDER ULTRASOUND THAT THE FLUID WAS NOT STAYING IN THE BALLOON. THE BALLOON WOULD NOT INFLATE. THE CATHETER SHAFT SEEMS TO BE OK. THEY FILLED THE BALLOON WITH FLUID AND FOUND TWO SMALL HOLES IN THE BALLOON. ANOTHER BAKRI BALLOON WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT WAS REPORTED AS BEING "WELL" POST-PROCEDURE. THE BALLOON HAS BEEN DISCARDED. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE ALLEGED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    944727 COOK BAKRI POSTPARTUM BALLOON WITH RAPID INSTILLATION COMPONENTS OQY INTRAUTERINE BALLOON OQY COOK INC 9031345 10827002242378

    Patients

    Seq Age Sex Outcome Treatment
    1