BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOK BAKRI POSTPARTUM BALLOON WITH RAPID INSTILLATION COMPONENTS

    MDR report key: 8217286 · Received January 4, 2019

    Report

    Report Number
    1820334-2019-00039
    Event Type
    Malfunction
    Date Received
    January 4, 2019
    Date of Event
    August 30, 2018
    Report Date
    January 18, 2019
    Manufacturer
    COOK INC
    Product Code
    OQY
    UDI-DI
    10827002242378
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER

    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 RECEIVED FOR AN EVALUATION. 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, QUALITY CONTROL DATA, AND TRENDS. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO NON-CONFORMANCES. A REVIEW OF THE SUB ASSEMBLY DEVICE HISTORY RECORDS ALSO REVEALED NO NON-CONFORMANCES. A SEARCH OF COMPLAINT RECORDS SHOWS THAT THIS COMPLAINT IS THE ONLY ONE ASSOCIATED WITH COMPLAINT LOT NUMBER 8322251. THE INSTRUCTIONS FOR USE (IFU) STATES THE PROPER WARNINGS, PRECAUTIONS, AND INSTRUCTIONS FOR USE. 1. REMOVE TENSION FROM BALLOON SHAFT. 2. REMOVE ANY VAGINAL PACKING. 3. USING AN APPROPRIATE SYRINGE, ASPIRATE THE CONTENTS OF THE BALLOON UNTIL FULLY DEFLATED. THE FLUID MAY BE REMOVED INCREMENTALLY TO ALLOW PERIODIC OBSERVATION OF THE PATIENT. 4. GENTLY RETRACT THE BALLOON FROM THE UTERUS AND VAGINAL CANAL AND DISCARD. NO PRODUCT HAS BEEN RETURNED FOR EVALUATION. THE INVESTIGATION FOUND THERE WERE NO OTHER COMPLAINTS RELATED TO THIS LOT NUMBER. THE CAUSE OF THE REPORTED ISSUE 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

    ADDITIONAL INFORMATION PROVIDED ON 03JAN2019. TO INFLATE THE BALLOON, SALINE AND THE SYRINGE AND TUBING INCLUDED IN THE KIT WAS USED.

    Additional Manufacturer Narrative · 1

    OCCUPATION: NON-HEALTHCARE PROFESSIONAL. 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 THAT DURING INSERTION OF A COOK BAKRI POSTPARTUM BALLOON WITH RAPID INSTILLATION COMPONENTS TO TREAT POST-PARTUM BLEEDING, THEY WERE UNABLE TO GET THE FLUID OUT OF THE BALLOON. A SECOND BALLOON FROM THE SAME LOT WAS USED, AND THE END USER WAS UNABLE TO GET THE FLUID OUT OF THE SECOND BALLOON AS WELL. THEY WERE ABLE TO SUCCESSFULLY COMPLETED THE PROCEDURE USING A THIRD BALLOON. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE ALLEGED MALFUNCTION. IT IS UNCLEAR WHETHER THEY WERE TESTING THE PATENCY OF THE BALLOONS PRIOR TO INSERTION OR IF THIS DIFFICULTY WAS DISCOVERED AFTER THE BALLOONS HAD BEEN INSERTED. ADDITIONAL INFORMATION WAS REQUESTED REGARDING THE PATIENT AND THE EVENT. THE COMPLAINANT IS UNABLE TO PROVIDE ANY ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12458 COOK BAKRI POSTPARTUM BALLOON WITH RAPID INSTILLATION COMPONENTS OQY INTRAUTERINE BALLOON OQY COOK INC 8322251 10827002242378

    Patients

    Seq Age Sex Outcome Treatment
    1