BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BAKRI TAMPONADE BALLOON CATHETER

    MDR report key: 8504993 · Received April 11, 2019

    Report

    Report Number
    1820334-2019-00776
    Event Type
    Malfunction
    Date Received
    April 11, 2019
    Date of Event
    March 22, 2019
    Report Date
    April 11, 2019
    Manufacturer
    COOK INC
    Product Code
    OQY
    UDI-DI
    10827002306735
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OCCUPATION: PHARMACIST. PMA/510(K) #: K170622. INVESTIGATION ¿ EVALUATION: THE COMPLAINT DEVICE WAS NOT RETURNED FOR AN EVALUATION. WITHOUT THE DEVICE, A DEVICE FAILURE ANALYSIS WAS UNABLE TO BE PERFORMED. A DOCUMENT BASED INVESTIGATION WAS CONDUCTED INCLUDING A REVIEW OF COMPLAINT HISTORY, DEVICE HISTORY RECORD, THE INSTRUCTIONS FOR USE, QUALITY CONTROL DATA, AND TRENDS. A REVIEW OF THE DEVICE HISTORY RECORD FOR THE COMPLAINT DEVICE PRODUCTION LOT REVEALED NO NON-CONFORMANCES. A REVIEW OF COMPLAINT HISTORY RECORDS SHOWS THERE ARE NO OTHER COMPLAINTS ASSOCIATED WITH THE COMPLAINT DEVICE LOT. THE INSTRUCTIONS FOR USE (IFU) PROVIDED WITH THIS PRODUCT INCLUDES THE FOLLOWING INFORMATION TO THE USER RELATED TO THE REPORTED FAILURE MODE: INSTRUCTIONS: USING THE ENCLOSED SYRINGE, BEGIN FILLING THE BALLOON TO THE PREDETERMINED VOLUME THROUGH THE STOPCOCK. COOK HAS CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. THE CAUSE OF THE EVENT COULD NOT BE ESTABLISHED. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS WARRANTED. 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 INITIALLY REPORTED THE BAKRI TAMPONADE BALLOON CATHETER FILLING VALVE IS DEFECTIVE. ADDITIONAL INFORMATION PROVIDED ON 26MAR2019 STATED THE VALVE WAS BROKEN (WAS IMPOSSIBLE TO INFLATE THE BALLOON) AND THEY REPLACED IT WITH A NEW ONE. THE PROCEDURE WAS LONGER THAN OTHER TIMES, BUT THE RESULT WAS POSITIVE. FURTHER CLARIFICATION WAS PROVIDED. DURING THE PROCEDURE TO STOP HEMORRHAGING FROM THE UTERUS, THE BAKRI TAMPONADE BALLOON CATHETER VALVE WAS STUCK. IT WAS IMPOSSIBLE TO INFLATE THE BALLOON. THE DOCTOR TRIED TO INFLATE THE BALLOON WITH MORE STRENGTH BUT NOTHING HAPPENED. HE HAD TO REMOVE THE BAKRI AND REPLACE IT WITH A NEW ONE. THERE WERE NO ADDITIONAL PROCEDURES REQUIRED AND THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT AS A RESULT OF THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299797 BAKRI TAMPONADE BALLOON CATHETER OQY INTRAUTERINE BALLOON OQY COOK INC G30673 9487939 10827002306735

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR