BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BAKRI TAMPONADE BALLOON CATHETER

    MDR report key: 7689531 · Received July 16, 2018

    Report

    Report Number
    1820334-2018-02051
    Event Type
    Malfunction
    Date Received
    July 16, 2018
    Date of Event
    June 4, 2018
    Report Date
    August 9, 2018
    Manufacturer
    COOK INC
    Product Code
    OQY
    UDI-DI
    10827002306735
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    INVESTIGATION ¿ EVALUATION: FUNCTIONAL TESTING OF THE RETURNED DEVICE WAS PERFORMED. THE INVESTIGATION ALSO INCLUDED REVIEW OF COMPLAINT HISTORY, THE DEVICE HISTORY RECORD, DRAWINGS, QUALITY CONTROL DATA, AND SPECIFICATIONS. ONE DEVICE WAS RETURNED FOR INVESTIGATION. A FUNCTIONAL TEST WAS PERFORMED AND IT WAS NOTED THAT THE WATER CAME OUT OF THE DRAINAGE PORT. THERE IS A LUMEN COMMUNICATION AT THE INFLATION LINE. THE COMPLAINT IS CONFIRMED BASED UPON EVALUATION OF THE RETURNED DEVICE. THE DEVICE HISTORY RECORD WAS REVIEWED AND IT WAS NOTED THERE WERE NO NON-CONFORMANCES ASSOCIATED WITH THE REPORTED FAILURE MODE. A REVIEW OF COMPLAINT HISTORY REVEALED THIS COMPLAINT TO BE THE ONLY ONE ASSOCIATED WITH COMPLAINT LOT NUMBER 8119790. A REVIEW OF RELEVANT MANUFACTURING DOCUMENTS WAS CONDUCTED. THIS DEVICE IS 100% INSPECTED VISUALLY FOR SURFACE IMPERFECTIONS AND FUNCTIONALLY TESTED FOR LEAKS, INFLATION, AND DEFLATION. A DEFINITIVE CAUSE FOR THIS ISSUE HAS NOT BEEN DETERMINED. COOK MEDICAL HAS NOTIFIED THE APPROPRIATE PERSONNEL AND WILL CONTINUE TO MONITOR THIS DEVICE VIA THE COMPLAINTS DATABASE FOR SIMILAR COMPLAINTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WITH LOWER UTERINE SEGMENT CESAREAN SECTION, DELIVERED 2 MALE TWINS, (B)(6). BECAUSE SEVERE ADHESIONS WERE FOUND BETWEEN THE PLACENTA AND THE UTERINE WALL, THE DOCTOR MANUALLY EVACUATED THE PLACENTA. THEN OXYTOCIN FOR INJECTION AND HEMABATE WAS USED ON THE PATIENT BUT THE PATIENT SUFFERED SURFACE OF PLACENTAL SEPARATION HEMORRHAGE DUE TO UTERINE ATONY. SO, A BAKRI BALLOON WAS USED TO STOP THE BLEEDING. THE PHYSICIAN PLACED THE BALLOON INTO THE UTERINE CAVITY AND INJECTED 350 ML SALINE. THEN THE DOCTOR FOUND THE DRAINING BLOOD A LITTLE BIT WHITER THAN IT SHOULD BE. IT WAS SUSPECTED THAT THE BALLOON WAS LEAKING. THE DOCTOR CHANGED TO ANOTHER NEW DEVICE AND UTERINE CONTRACTION RECOVERY AND THE HEMORRHAGE DECREASED. THROUGH INSPECTION, FOUND THAT THE DRAINAGE TUBE WAS CONNECTED WITH THE INJECTION PIPELINE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Description of Event or Problem · 1

    NO NEW EVENT INFORMATION HAS BEEN RECEIVED SINCE THE LAST REPORT WAS SUBMITTED ON 16-JUL-2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    534195 BAKRI TAMPONADE BALLOON CATHETER OQY INTRAUTERINE BALLOON OQY COOK INC 8119790 10827002306735

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR