BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOK BAKRI POSTPARTUM BALLOON WITH RAPID INSTILLATION COMPONENTS

    MDR report key: 7663622 · Received July 5, 2018

    Report

    Report Number
    1820334-2018-01837
    Event Type
    Injury
    Date Received
    July 5, 2018
    Date of Event
    June 8, 2018
    Report Date
    August 31, 2018
    Manufacturer
    COOK INC
    Product Code
    OQY
    UDI-DI
    10827002242378
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNCHANGED, OR UNAVAILABLE. RESULTS CODE: APPROPRIATE TERM/CODE NOT AVAILABLE (4247) ¿ LUMEN COMMUNICATION CONCLUSION CODE: CAUSE NOT ESTABLISHED (4315) INVESTIGATION ¿ EVALUATION ADDITIONAL INFORMATION: CONCOMITANT MEDICAL PRODUCTS. A VISUAL INSPECTION AND FUNCTIONAL TESTING OF THE RETURNED DEVICE WAS CONDUCTED. A DOCUMENT BASED INVESTIGATION WAS ALSO PERFORMED. THIS INCLUDED A REVIEW OF COMPLAINT HISTORY, THE DEVICE HISTORY RECORD, DRAWINGS, INSTRUCTIONS FOR USE, AND QUALITY CONTROL DATA. ONE DEVICE WAS RETURNED FOR INVESTIGATION. THE DEVICE WAS RETURNED WITH THE Y-CONNECTION CUT OFF. A FUNCTIONAL TEST OF THE BALLOON WAS CONDUCTED BY INJECTING WATER INTO THE FILL LUMEN. THE BALLOON INFLATED PROPERLY; NO LEAKS NOTED AND NO WATER BACKED UP IN THE OTHER LUMEN. THE Y-CONNECTION WAS TESTED AND WATER BACK FLOWED INTO THE DRAINAGE LUMEN INDICATING A LUMEN COMMUNICATION BETWEEN THE INFLATION AND DRAINAGE LUMENS. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO NON-CONFORMANCES THAT MAY HAVE CONTRIBUTED TO THIS FAILURE MODE. A COMPLAINT HISTORY SEARCH REVEALED THIS IS THE ONLY COMPLAINT ASSOCIATED WITH LOT NUMBER 8283297. THE INSTRUCTION FOR USE (IFU) INSTRUCTS TO REMOVE THE STOPCOCK TO AID IN PLACEMENT AND REATTACH PRIOR TO FILLING THE BALLOON. 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. THIS PRODUCT IS 100 % LEAK TESTED. CURRENT CONTROLS FOR MANUFACTURING ARE IN PLACE TO ASSURE FUNCTIONALITY AND DEVICE INTEGRITY PRIOR TO SHIPPING. THERE IS NO INDICATION THAT A DESIGN PROCESS OR RELATED FAILURE MODE CONTRIBUTED TO THIS EVENT. A CONCLUSION FOR THIS DEVICE ISSUE COULD NOT BE ESTABLISHED. 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

    THERE HAS BEEN NO NEW INFORMATION RECEIVED SINCE THE LAST REPORT WAS SUBMITTED ON (B)(6)2018. THE FACILITY WOULD NOT PROVIDE ANY OF THE ADDITIONAL INFORMATION REQUESTED DUE TO PRIVACY CONCERNS.

    Additional Manufacturer Narrative · 1

    (B)(4). PMA/510K # 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, AFTER A CAESAREAN SECTION AND POST PARTUM HEMORRHAGE, THE DOCTOR INSERTED A COOK BAKRI POSTPARTUM BALLOON WITH RAPID INSTILLATION COMPONENTS INTO THE UTERINE CAVITY AND STARTED TO INFLATE WITH SALINE. THE SALINE DID NOT GO INSIDE THE BALLOON BUT EXITED FROM THE DRAINAGE PORT, SO IT WAS NOT POSSIBLE TO FILL THE BALLOON. ANOTHER SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. IT WAS REPORTED THAT THE PATIENT RECEIVED A BLOOD TRANSFUSION DUE TO THE DELAY IN TREATMENT. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED. REQUESTS WERE MADE FOR THE FOLLOWING INFORMATION, HOWEVER THE CUSTOMER REFUSES TO PROVIDE ANY FURTHER INFORMATION DUE TO PRIVACY CONCERNS. 1. PRIOR TO BALLOON INSERTION, PLEASE QUANTIFY BLOOD LOSS. FOR EXAMPLE: X00ML/CC: 2. PLEASE QUANTIFY HOW MUCH BLOOD LOSS THE PATIENT EXPERIENCED IN TOTAL. FOR EXAMPLE: X00ML/CC. 3. PLEASE PROVIDE PATIENTS CRITICAL LAB VALUES, FOR EXAMPLE: HT/HCT LEVELS, CBC, ANY LABS THAT WERE DRAWN PRIOR TO AND POST PROCEDURE: A. PRIOR TO PROCEDURE: B. POST PROCEDURE: 4. PLEASE PROVIDE HOW MANY GESTATIONAL WEEKS THE PATIENT WAS: 5. PLEASE PROVIDE PATIENT AGE AND WEIGHT: 6. PLEASE PROVIDE ANY RELEVANT HEALTH HISTORY, INCLUDING PRE-EXISTING CONDITIONS (EXAMPLE: GESTATIONAL DIABETES, PLACENTA PREVIA, SMOKING, ALCOHOLISM, ETC.): 7. THE RECORD STATES THAT THE PATIENT WAS TRANSFUSED, PLEASE QUANTIFY THE AMOUNT OF BLOOD/BLOOD PRODUCT GIVEN IN MILLILITERS (ML): 8. WHAT WAS PATIENT OUTCOME POST-TRANSFUSION:

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    507251 COOK BAKRI POSTPARTUM BALLOON WITH RAPID INSTILLATION COMPONENTS OQY INTRAUTERINE BALLOON OQY COOK INC 8283297 10827002242378

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention