BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BAKRI TAMPONADE BALLOON CATHETER

    MDR report key: 8170790 · Received December 17, 2018

    Report

    Report Number
    1820334-2018-03783
    Event Type
    Malfunction
    Date Received
    December 17, 2018
    Date of Event
    December 3, 2018
    Report Date
    January 15, 2019
    Manufacturer
    COOK INC
    Product Code
    OQY
    UDI-DI
    10827002306735
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION ¿ EVALUATION A VISUAL INSPECTION AND FUNCTIONAL TESTING OF THE RETURNED DEVICE WAS CONDUCTED. A VIDEO WAS ALSO PROVIDED FOR REVIEW. A DOCUMENT BASED INVESTIGATION INCLUDED A REVIEW OF THE VIDEO, COMPLAINT HISTORY, THE DEVICE HISTORY RECORD, DRAWINGS, INSTRUCTIONS FOR USE, QUALITY CONTROL DATA, AND TRENDS. ONE DEVICE WAS RETURNED FOR INVESTIGATION. THE RETURNED PACKAGING CONFIRMS LOT NUMBER 9161158. A LEAK TEST WAS PERFORMED AND DETERMINED THERE IS A LEAK AT THE STOPCOCK. A REVIEW OF THE PROVIDED VIDEO SHOWS THE FITTINGS LEAKING. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO NON-CONFORMANCES WERE IDENTIFIED THAT WOULD BE RELATED TO THE REPORTED FAILURE. A COMPLAINT HISTORY SEARCH REVEALED THIS IS THE ONLY COMPLAINT ASSOCIATED WITH LOT NUMBER 9161158. THE INSTRUCTIONS FOR USE (IFU) PROVIDES THE PROPER WARNINGS, PRECAUTIONS, AND INSTRUCTIONS FOR USE. THE CAUSE OF THE LEAKING WAS NOT 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. 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

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

    Additional Manufacturer Narrative · 1

    OCCUPATION: NON-HEALTHCARE PROFESSIONAL. PMA/510(K) #: K170622. DEVICE CODE: STOPCOCK, FLUID LEAK IS NOT LABELED. 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 THE USER PLANNED TO USE THE J-SOS-100500 TO STOP POSTPARTUM UTERINE BLEEDING AS THE PATIENT LOST 500ML BLOOD AFTER DELIVERY BY CAESAREAN SECTION. THE USER FOUND A LEAKAGE ISSUE AT THE STOPCOCK WHILE INJECTING SALINE, BUT AT THE STAGE THE BALLOON HAS BEEN INFLATED A BIT IN UTERUS AND COULD NOT BE RETRACTED. IN ORDER TO STOP BLEEDING THE USER DECIDED TO CUT THE STOPCOCK AT THE DISTAL END WHERE IT WAS LEAKING AND JOINED THE PROXIMAL END OF THE STOPCOCK WITH A CATHETER TO CONTINUE TO INFLATE THE BALLOON. THE BLEEDING EVENTUALLY STOPPED. AS REPORTED, THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES AND THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1009066 BAKRI TAMPONADE BALLOON CATHETER OQY INTRAUTERINE BALLOON OQY COOK INC 9161158 10827002306735

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR