BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOK BAKRI POSTPARTUM BALLOON WITH RAPID INSTILLATION COMPONENTS

    MDR report key: 22003170 · Received May 12, 2025

    Report

    Report Number
    1820334-2025-00511
    Event Type
    Injury
    Date Received
    May 12, 2025
    Date of Event
    April 24, 2025
    Report Date
    July 24, 2025
    Manufacturer
    COOK INC
    Product Code
    OQY
    UDI-DI
    00827002242371
    PMA / PMN Number
    K170622
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    AS REPORTED, TWO COOK BAKRI POSTPARTUM BALLOON WITH RAPID INSTILLATION COMPONENTS (083082 AND 083081) LOST SALINE DURING TREATMENT OF SEVERE POST-PARTUM HEMORRHAGE (PPH) FOLLOWING A CESAREAN DELIVERY. PPH OCCURRED APPROXIMATELY THREE HOURS POST-DELIVERY AND NECESSITATED THE PATIENT¿S RETURN TO THE OPERATING ROOM. THE FIRST BALLOON (REFERENCE REPORT 083081) WAS FILLED WITH 300 CC SALINE SOLUTION AND PLACED TRANSVAGINALLY USING A BLUNT CLAMP ON THE TUBING. APPROXIMATELY THIRTY MINUTES LATER, THE BALLOON WAS NOTED TO BE LOSING FLUID. A SECOND BAKRI POSTPARTUM BALLOON WITH RAPID INSTILLATION COMPONENTS (REFERENCE THIS REPORT 083082) WAS FILLED WITH 300 CC SALINE SOLUTION, PLACED TRANSVAGINALLY BY HAND AND AGAIN, AFTER AN ESTIMATED THIRTY MINUTES, THE BALLOON WAS NOTED TO BE LOSING FLUID. THE BALLOON WAS REMOVED, AND A HOLE WAS SEEN IN THE BALLOON ITSELF. A RELAPAROTOMY WAS PERFORMED WITH THE PLACING OF HAYMAN UTERINE COMPRESSION SUTURES AND HEMOSTASIS WAS FINALLY ACHIEVED. PATIENT BLOOD LOSS WAS REPORTEDLY 3L AND THE PATIENT RECEIVED FOUR UNITS OF FRESH FROZEN PLASMA AND TWO UNITS OF PACKED RED BLOOD CELLS. THE PATIENT EXPERIENCED PROLONGED HOSPITALIZATION. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. REVIEWS OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD (DHR), INSTRUCTIONS FOR USE (IFU), MANUFACTURER¿S INSTRUCTIONS (MI), AND QUALITY CONTROL (QC) PROCEDURES WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE, NO FUNCTIONAL TESTING OR VISUAL INSPECTIONS COULD BE PERFORMED. A REVIEW OF THE DEVICE MASTER RECORD (DMR) CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOUND NO RELATED NON-CONFORMANCES REPORTED FOR THE FAILURE MODE. A COMPLAINT HISTORY DATABASE SEARCH SHOWED NO OTHER RELATED COMPLAINTS ASSOCIATED WITH THE FAILURE MODE FOR THE COMPLAINT DEVICE LOT. BECAUSE THERE ARE NO RELATED NON-CONFORMANCES, ADEQUATE INSPECTION ACTIVITIES HAVE BEEN ESTABLISHED, THERE IS OBJECTIVE EVIDENCE THAT THE DHR WAS FULLY EXECUTED, AND NO OTHER LOT RELATED COMPLAINTS THAT HAVE BEEN RECEIVED FROM THE FIELD, IT WAS CONCLUDED THAT THERE IS NO EVIDENCE THAT NONCONFORMING PRODUCT EXISTS IN HOUSE OR IN FIELD. COOK ALSO REVIEWED PRODUCT LABELING; THE IFU SUPPLIED WITH THE DEVICE STATES THE FOLLOWING IN CONSIDERATION OF THE REPORTED FAILURE MODE: HOW SUPPLIED: "UPON REMOVAL FROM THE PACKAGE, INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED." BASED UPON THE AVAILABLE INFORMATION, NO PRODUCT RETURNED, AND RESULTS OF THE INVESTIGATION, COOK HAS CONCLUDED THAT THE CAUSE FOR THE COMPLAINT COULD NOT BE ESTABLISHED. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. COOK WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS PER THE RISK ASSESSMENT, NO FURTHER ACTION IS REQUIRED. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED, THAT A DEATH OR SERIOUS INJURY OCCURRED, NOR THAT ANY COOK DEVICE CAUSED, CONTRIBUTED TO, OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Additional Manufacturer Narrative · 0

    E1- CUSTOMER ADDRESS 1: (B)(6). E2 - CUSTOMER PHONE NUMBER: (B)(6). THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE. 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 INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

    Description of Event or Problem · 0

    AS REPORTED, TWO COOK BAKRI POSTPARTUM BALLOON WITH RAPID INSTILLATION COMPONENTS (B)(6) LOST SALINE DURING TREATMENT OF SEVERE POST-PARTUM HEMORRHAGE (PPH) FOLLOWING A CESAREAN DELIVERY. PPH OCCURRED APPROXIMATELY THREE HOURS POST-DELIVERY AND NECESSITATED THE PATIENT¿S RETURN TO THE OPERATING ROOM. THE FIRST BALLOON (REFERENCE REPORT (B)(4)) WAS FILLED WITH 300 CC SALINE SOLUTION AND PLACED TRANSVAGINALLY USING A BLUNT CLAMP ON THE TUBING. APPROXIMATELY THIRTY MINUTES LATER, THE BALLOON WAS NOTED TO BE LOSING FLUID. A SECOND BAKRI POSTPARTUM BALLOON WITH RAPID INSTILLATION COMPONENTS (REFERENCE THIS REPORT (B)(4)) WAS FILLED WITH 300 CC SALINE SOLUTION, PLACED TRANSVAGINALLY BY HAND AND AGAIN, AFTER AN ESTIMATED THIRTY MINUTES, THE BALLOON WAS NOTED TO BE LOSING FLUID. THE BALLOON WAS REMOVED, AND A HOLE WAS SEEN IN THE BALLOON ITSELF. A RELAPAROTOMY WAS PERFORMED WITH THE PLACING OF HAYMAN UTERINE COMPRESSION SUTURES AND HEMOSTASIS WAS FINALLY ACHIEVED. PATIENT BLOOD LOSS WAS REPORTEDLY 3L AND THE PATIENT RECEIVED FOUR UNITS OF FRESH FROZEN PLASMA AND TWO UNITS OF PACKED RED BLOOD CELLS. THE PATIENT EXPERIENCED PROLONGED HOSPITALIZATION. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371076 COOK BAKRI POSTPARTUM BALLOON WITH RAPID INSTILLATION COMPONENTS OQY INTRAUTERINE TAMPONADE BALLOON OQY COOK INC G24237 16113595 00827002242371

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Female Required Intervention| H