BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOK BAKRI POSTPARTUM BALLOON WITH RAPID INSTILLATION COMPONENTS

    MDR report key: 17195557 · Received June 23, 2023

    Report

    Report Number
    1820334-2023-00811
    Event Type
    Injury
    Date Received
    June 23, 2023
    Date of Event
    June 7, 2023
    Report Date
    August 15, 2023
    Manufacturer
    COOK INC
    Product Code
    OQY
    UDI-DI
    10827002242378
    PMA / PMN Number
    K170622
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNCHANGED, OR UNAVAILABLE. SUMMARY OF EVENT: AS REPORTED BY SHENZHEN INLIFE SCI. CO.,LTD. ON (B)(6)2023, A PATIENT HAD BLEEDING FOLLOWING A CESAREAN SECTION AND HAD LOST ~500ML OF BLOOD. A 'COOK BAKRI POSTPARTUM BALLOON WITH RAPID INSTILLATION COMPONENTS' (RPN: (B)(4); LOT:14433619) WAS PLACED TRANSABDOMINALLY IN AN ATTEMPT TO STOP THE BLEEDING. THE BALLOON WAS INFLATED WITH APPROXIMATELY 300ML OF WATER BEFORE THE BALLOON RUPTURED. THE BALLOON WAS NOT INFLATED PRIOR TO THE CLOSURE OF THE HYSTEROTOMY. THE USER REPLACED THE DEVICE WITH ANOTHER BALLOON AND HEMOSTASIS WAS ACHIEVED. THE PATIENT LOST AN ADDITIONAL ~800ML OF BLOOD FOLLOWING THE DEVICE ISSUE; THE TOTAL ESTIMATED BLOOD LOSS WAS ~1300ML. THE PATIENT REQUIRED A BLOOD TRANSFUSION, IT IS UNKNOWN HOW MANY UNITS WERE TRANSFUSED. THE DEVICE WAS NOT HANDLED BY OR IN THE PROXIMITY OF ANY METAL TOOLS (I.E., FORCEPS OR SUTURE NEEDLES) THAT MAY HAVE DAMAGED THE BALLOON. THE PATIENT WAS HEMODYNAMICALLY STABLE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL INTERVENTION AND DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. INVESTIGATION EVALUATION: REVIEWS OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD (DHR), INSTRUCTIONS FOR USE (IFU), AND QUALITY CONTROL (QC) PROCEDURES, AS WELL AS A VISUAL INSPECTION OF THE RETURNED DEVICE, WERE CONDUCTED DURING THE INVESTIGATION. ONE USED COOK BAKRI POSTPARTUM BALLOON WITH RAPID INSTILLATION COMPONENTS DEVICE WITH NO ORIGINAL PACKAGING WAS RETURNED FOR INVESTIGATION AND A VISUAL INSPECTION WAS CONDUCTED. DEVICE FAILURE ANALYSIS FOUND THE BALLOON MATERIAL WAS SPLIT THE ENTIRE LENGTH OF THE BALLOON. ADDITIONALLY, A DOCUMENT-BASED INVESTIGATION EVALUATION WAS 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 SEARCH OF THE DEVICE HISTORY RECORD FOUND NO RELATED NON-CONFORMANCES REPORTED FOR LOT 14433619 AND RELATED SUBASSEMBLY LOTS. A COMPLAINT HISTORY DATABASE SEARCH SHOWED NO OTHER RELATED COMPLAINTS ASSOCIATED WITH 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. THERE IS NO EVIDENCE TO SUGGEST THIS DEVICE WAS MANUFACTURED OUT OF SPECIFICATION. COOK ALSO REVIEWED PRODUCT LABELING. THE IFU (T_J-SOSR_REV4; ¿BAKRI POSTPARTUM BALLOON¿) SUPPLIED WITH THE DEVICE STATES THE FOLLOWING IN CONSIDERATION OF THE REPORTED FAILURE MODE: - PRECAUTIONS: ¿AVOID EXCESSIVE FORCE WHEN INSERTING THE BALLOON INTO THE UTERUS.¿ - HOW SUPPLIED: "UPON REMOVAL FROM THE PACKAGE, INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED." BASED UPON THE AVAILABLE INFORMATION, INSPECTION OF THE RETURNED DEVICE, 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 EVENTS. PER THE QUALITY ENGINEERING 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 POSTAL CODE/ PHONE = (B)(6). E3: CUSTOMER OCCUPATION = UNKNOWN. 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 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.

    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, A PATIENT HAD BLEEDING FOLLOWING A CESAREAN SECTION AND HAD LOST ~500ML OF BLOOD. A 'COOK BAKRI POSTPARTUM BALLOON WITH RAPID INSTILLATION COMPONENTS' WAS PLACED TRANSABDOMINALLY IN AN ATTEMPT TO STOP THE BLEEDING. THE BALLOON WAS INFLATED WITH APPROXIMATELY 300ML OF WATER BEFORE THE BALLOON RUPTURED. THE BALLOON WAS NOT INFLATED PRIOR TO THE CLOSURE OF THE HYSTEROTOMY. THE USER REPLACED THE DEVICE WITH ANOTHER BALLOON AND HEMOSTASIS WAS ACHIEVED. THE PATIENT LOST AN ADDITIONAL ~800ML OF BLOOD FOLLOWING THE DEVICE ISSUE; THE TOTAL ESTIMATED BLOOD LOSS WAS ~1300ML. THE PATIENT REQUIRED A BLOOD TRANSFUSION, IT IS UNKNOWN HOW MANY UNITS WERE TRANSFUSED. THE DEVICE WAS NOT HANDLED BY OR IN THE PROXIMITY OF ANY METAL TOOLS (I.E., FORCEPS OR SUTURE NEEDLES) THAT MAY HAVE DAMAGED THE BALLOON. THE PATIENT WAS HEMODYNAMICALLY STABLE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL INTERVENTION AND DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1865913 COOK BAKRI POSTPARTUM BALLOON WITH RAPID INSTILLATION COMPONENTS OQY INTRAUTERINE BALLOON OQY COOK INC G24237 14433619 10827002242378

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Female Other