BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOK BAKRI POSTPARTUM BALLOON WITH RAPID INSTILLATION COMPONENTS

    MDR report key: 7691286 · Received July 16, 2018

    Report

    Report Number
    1820334-2018-02053
    Event Type
    Malfunction
    Date Received
    July 16, 2018
    Date of Event
    June 11, 2018
    Report Date
    August 22, 2018
    Manufacturer
    COOK INC
    Product Code
    OQY
    UDI-DI
    10827002242378
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H6 - METHOD CODES: 4114, DEVICE NOT RETURNED. H6 - CONCLUSION CODES: 4315, CAUSE NOT ESTABLISHED. THE COMPLAINT DEVICE WAS NOT RETURNED FOR AN EVALUATION AND NO PHOTOGRAPHS WERE 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, DRAWINGS, QUALITY CONTROL DATA, AND SPECIFICATIONS. THE DEVICE HISTORY RECORD WAS REVIEWED AND NOTED THERE ARE NO CONFORMANCES THAT MAY HAVE CONTRIBUTED TO THIS INCIDENT. A REVIEW OF COMPLAINT HISTORY RECORDS REVEALED THIS COMPLAINT TO BE THE ONLY ONE ASSOCIATED WITH COMPLAINT LOT NUMBER 8433291. THERE IS NO INDICATION THAT A DESIGN PROCESS OR RELATED FAILURE MODE CONTRIBUTED TO THIS EVENT. CURRENT CONTROLS FOR MANUFACTURING ARE IN PLACE TO ASSURE FUNCTIONALITY AND DEVICE INTEGRITY PRIOR TO SHIPPING. MEASURES HAVE BEEN INITIATED TO ADDRESS THE REPORTED FAILURE MODE. 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.

    Additional Manufacturer Narrative · 0

    THE PRODUCT CARTON CONFIRMING REPORTED LOT NUMBER WAS RETURNED. THERE WAS NO DEVICE INSIDE THE CARTON. THERE IS NO CHANGE TO THE PREVIOUS INVESTIGATION CONCLUSION; CAUSE NOT ESTABLISHED. 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 HAS BEEN RECEIVED. IT WAS REPORTED THE PATIENT WAS GIVEN SYNTOCINON, HEXACIL, AND NALADOR DURING THE PROCEDURE. THEY USED A SECOND BAKRI BALLOON TO ACHIEVE HEMOSTASIS. POSTPARTUM HEMORRHAGE STOPPED. THE DEVICE WAS THROWN AWAY.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION HAS BEEN RECEIVED SINCE THE LAST REPORT WAS SUBMITTED ON 08AUG2018.

    Description of Event or Problem · 0

    THERE IS NO NEW EVENT INFORMATION TO REPORT.

    Additional Manufacturer Narrative · 1

    PMA/510(K) #: 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 THAT ON (B)(6) 2018 WHILE IN THE BIRTH ROOM, IT WAS IMPOSSIBLE TO USE THE (BAKRI BALLOON) DEVICE BECAUSE THE BALLOON WAS PUNCTURED. THEY CHANGED THE DEVICE. ALSO REPORTED, THIS WAS AN EMERGENCY AND THUS STRESS AND WASTE OF TIME. THERE WERE NO CLINICAL CONSEQUENCES. ADDITIONAL INFORMATION WAS RECEIVED ON 16JUL2018. THE PATIENT WAS TREATED WITH NALADOR AND THE BAKRI BALLOON FOR POST PARTUM HEMORRHAGE. WHEN THE FIRST BALLOON DID NOT INFLATE, THEY CHANGED TO A 2ND BAKRI BALLOON TO STOP THE BLEEDING. THERE WERE NO ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    532339 COOK BAKRI POSTPARTUM BALLOON WITH RAPID INSTILLATION COMPONENTS OQY INTRAUTERINE BALLOON OQY COOK INC G24237 8433291 10827002242378

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR