BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BAKRI TAMPONADE BALLOON CATHETER

    MDR report key: 8039820 · Received November 5, 2018

    Report

    Report Number
    1820334-2018-03241
    Event Type
    Malfunction
    Date Received
    November 5, 2018
    Date of Event
    October 14, 2018
    Report Date
    November 26, 2018
    Manufacturer
    COOK INC
    Product Code
    OQY
    UDI-DI
    10827002306735
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION ¿ EVALUATION: THE COMPLAINT DEVICE WAS NOT RETURNED FOR AN EVALUATION. PHOTOGRAPHS WERE PROVIDED BY THE CUSTOMER. 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, INSTRUCTIONS FOR USE, MANUFACTURING INSTRUCTIONS, QUALITY CONTROL DATA, SPECIFICATIONS, AND TRENDS. A VISUAL EXAMINATION OF THE PROVIDED PHOTOS REVEALED A SPLIT IN THE BALLOON MATERIAL. A REVIEW OF THE DEVICE HISTORY OBSERVED NO NON-CONFORMANCES RELATED TO THE REPORTED FAILURE MODE. A REVIEW OF COMPLAINT HISTORY RECORDS REVEALED THERE ARE NO OTHER COMPLAINTS ASSOCIATED WITH THE COMPLAINT DEVICE LOT NUMBER 8667952. THIS DEVICE IS SHIPPED WITH THE INSTRUCTIONS FOR USE (IFU) WHICH PROVIDES THE PROPER WARNINGS, PRECAUTIONS, AND INSTRUCTIONS FOR USE. THE COMPLAINT WAS CONFIRMED BASED ON THE PHOTOS PROVIDED BY THE CUSTOMER. A DEFINITIVE CAUSE OF THIS FAILURE COULD NOT BE ESTABLISHED. MEASURES HAVE BEEN INITIATED TO ADDRESS THIS FAILURE MODE. 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 · 0

    THERE HAS BEEN NO NEW INFORMATION RECEIVED SINCE THE LAST REPORT WAS SUBMITTED.

    Additional Manufacturer Narrative · 1

    PMA/510K # 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 INITIALLY REPORTED, THE BALLOON OF THE BAKRI TAMPONADE BALLOON CATHETER PUNCTURED SECONDS AFTER IT HAD BEEN INFLATED. ADDITIONAL INFORMATION WAS OBTAINED FROM THE DOCTOR, IT WAS A CLASSIC HEMORRHAGE POSTPARTUM (HPP). THE BALLOON WAS PLACED BY HAND INTO THE UTERINE CAVITY, INFLATED TO 500 ML. THE MOMENT HE PLACED SOME SOAKED GAUZE IN THE VAGINA TO HOLD THE BALLOON IN PLACE THE BALLOON "EXPLODED." WHEN HE REMOVED IT, HE NOTICED A ¿SHARP CLEAN¿ TEAR ON THE BALLOON. A NEW BAKRI WAS USED AND THE HPP WAS CONTAINED. ADDITIONAL INFORMATION HAS BEEN REQUESTED REGARDING THE PATIENT AND THE EVENT. AT THE TIME OF THIS REPORT, NO FURTHER INFORMATION HAS BEEN PROVIDED. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE ALLEGED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    880558 BAKRI TAMPONADE BALLOON CATHETER OQY INTRAUTERINE BALLOON OQY COOK INC 8667952 10827002306735

    Patients

    Seq Age Sex Outcome Treatment
    1