BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BAKRI TAMPONADE BALLOON CATHETER

    MDR report key: 8074020 · Received November 15, 2018

    Report

    Report Number
    1820334-2018-03380
    Event Type
    Malfunction
    Date Received
    November 15, 2018
    Date of Event
    November 1, 2018
    Report Date
    December 6, 2018
    Manufacturer
    COOK INC
    Product Code
    OQY
    UDI-DI
    10827002306735
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNCHANGED, OR UNAVAILABLE. ADDITIONAL INFORMATION: INVESTIGATION ¿ EVALUATION. A VISUAL INSPECTION AND FUNCTIONAL TESTING OF THE RETURNED DEVICE WAS CONDUCTED. A DOCUMENT BASED INVESTIGATION WAS ALSO PERFORMED. THIS INCLUDED A REVIEW OF COMPLAINT HISTORY, THE DEVICE HISTORY RECORD, INSTRUCTIONS FOR USE, AND SPECIFICATIONS. ONE DEVICE WAS RETURNED FOR INVESTIGATION. THE RETURNED PACKAGING CONFIRMS LOT NUMBER 8278906. FUNCTIONAL TESTING WAS PERFORMED USING WATER AND A SYRINGE. VISUAL EXAMINATION NOTED A LEAK IN THE SEAM OF THE BALLOON CATHETER MATERIAL NEAR THE HUB. THE DEVICE HISTORY RECORD FOR THE COMPLAINT DEVICE LOT WAS REVIEWED. THERE WERE NO NON-CONFORMANCES. A COMPLAINT HISTORY SEARCH REVEALED THIS IS THE ONLY COMPLAINT ASSOCIATED WITH LOT NUMBER 8278906. THE INSTRUCTIONS FOR USE (IFU) PROVIDES THE PROPER WARNINGS, PRECAUTIONS, AND INSTRUCTIONS FOR USE. THE CAUSE FOR THIS SPECIFIC 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. 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

    (B)(6). 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.

    Description of Event or Problem · 1

    STERILE WATER LEAKED FROM THE SHAFT WHEN IT WAS INJECTED THROUGH THE DEVICE PRIOR TO PATIENT CONTACT. THE BAKRI TAMPONADE BALLOON CATHETER WAS NOT USED. NO FURTHER INFORMATION HAS BEEN PROVIDED AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    916148 BAKRI TAMPONADE BALLOON CATHETER OQY INTRAUTERINE BALLOON OQY COOK INC 8278906 10827002306735

    Patients

    Seq Age Sex Outcome Treatment
    1