BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BAKRI TAMPONADE BALLOON CATHETER

    MDR report key: 8568762 · Received May 1, 2019

    Report

    Report Number
    1820334-2019-00913
    Event Type
    Malfunction
    Date Received
    May 1, 2019
    Date of Event
    April 2, 2019
    Report Date
    June 28, 2019
    Manufacturer
    COOK INC
    Product Code
    OQY
    UDI-DI
    10827002306735
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. ADDITIONAL INFORMATION: CONCOMITANT MEDICAL PRODUCTS. INVESTIGATION ¿ EVALUATION A VISUAL INSPECTION AND FUNCTIONAL TESTING OF THE RETURNED DEVICE WAS CONDUCTED. A DOCUMENT BASED INVESTIGATION WAS ALSO PERFORMED INCLUDING A REVIEW OF COMPLAINT HISTORY, THE DEVICE HISTORY RECORD, MANUFACTURING INSTRUCTIONS, QUALITY CONTROL DATA, INSTRUCTIONS FOR USE (IFU), SPECIFICATIONS AND TRENDS. THE COMPLAINANT RETURNED ONE J-SOS-100500 BAKRI BALLOON CATHETER FOR INVESTIGATION. REPORTED LOT NUMBER CONFIRMED. A VISUAL EXAMINATION PERFORMED ON THE CATHETER CONFIRMED DEVICE WAS RETURNED WITH LIQUID INSIDE THE CATHETER. THERE WAS NO VISIBLE DAMAGE ON THE BALLOON OR CATHETER. A FUNCTION TEST WAS PERFORMED BY INFLATING THE BALLOON WITH 300ML OF TAP WATER. NO LEAK DETECTED AROUND THE BALLOON AREA, NO LEAKS OBSERVED BETWEEN CATHETER LUMENS. WHEN PRESSURE WAS APPLIED TO THE BALLOON, WATER LEAKED AT THE STOPCOCK WHEN THE STOPCOCK WAS NOT PROPERLY CLOSED. WHEN STOPCOCK WAS CLOSED PROPERLY, NO LEAK WAS DETECTED. WATER DRAINED PROPERLY FROM THE CATHETER. THERE WERE NO LEAKS DETECTED AT THE CATHETER JOINT. A DEVICE HISTORY RECORD (DHR) REVIEW FOR THIS LOT SHOWS NO NON-CONFORMANCES. A REVIEW OF COMPLAINT HISTORY REVEALED NO OTHER COMPLAINTS ASSOCIATED WITH THE COMPLAINT DEVICE LOT NUMBER. BASED ON THE INVESTIGATION EVALUATION, THERE IS NO INDICATION THAT A DESIGN OR PROCESS RELATED FAILURE MODE CONTRIBUTED TO THIS EVENT. CURRENT CONTROLS FOR MANUFACTURING ARE IN PLACE TO ASSURE FUNCTIONALITY AND DEVICE INTEGRITY PRIOR TO SHIPPING. REVIEW OF PRODUCTION AND QUALITY DOCUMENTATION DID NOT OBSERVE ANY SPECIFIC ISSUES WITH CURRENT MANUFACTURING OR QUALITY CONTROLS THAT MAY HAVE CONTRIBUTED TO THIS INCIDENT. INSTRUCTIONS FOR USE (IFU) WARNS THE MAXIMUM INFLATION IS 500ML. DO NOT OVER INFLATE THE BALLOON. BALLOON SHOULD BE INFLATED WITH STERILE LIQUID. BALLOON SHOULD NEVER BE INFLATED WITH AIR, CARBON DIOXIDE OR ANY GAS. THE IFU ALSO PRECAUTIONS TO AVOID EXCESSIVE FORCE WHEN INSERTING THE BALLOON INTO THE UTERUS. THE MOST PROBABLE CAUSE OF THE DEVICE FAILURE WAS IMPROPER CLOSURE OF THE STOPCOCK DURING USE. BASED ON THE AVAILABLE INFORMATION, THE MOST LIKELY CAUSE OF THE EVENT WAS DETERMINED TO BE UNINTENDED USE ERROR. COOK HAS CONCLUDED THAT THE USER'S FAILURE TO FOLLOW INSTRUCTIONS CONTRIBUTED TO THIS INCIDENT. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS WARRANTED. THE APPROPRIATE INTERNAL PERSONNEL HAVE BEEN NOTIFIED AND WE WILL CONTINUE TO MONITOR 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 IS NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

    Additional Manufacturer Narrative · 1

    PMA/510K # K170622. 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 IS REPORTED DURING TREATMENT OF UTERINE BLEEDING AFTER DELIVERY USING A BAKRI TAMPONADE BALLOON CATHETER, LEAKAGE OCCURRED AT THE JOINT OF THE CATHETER. A SECOND BAKRI WAS PLACED AND HEMOSTASIS WAS ACHIEVED. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE ALLEGED MALFUNCTION. ADDITIONAL INFORMATION HAS BEEN REQUESTED REGARDING THE PATIENT AND THE EVENT. AT THE TIME OF THIS REPORT, NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364854 BAKRI TAMPONADE BALLOON CATHETER OQY INTRAUTERINE BALLOON OQY COOK INC G30673 8142545 10827002306735

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR