BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BALLOON UTERINE STENT

    MDR report key: 8214403 · Received January 3, 2019

    Report

    Report Number
    1820334-2019-00038
    Event Type
    Malfunction
    Date Received
    January 3, 2019
    Date of Event
    January 2, 2019
    Report Date
    February 11, 2019
    Manufacturer
    COOK INC
    Product Code
    KNA
    UDI-DI
    00827002170803
    PMA / PMN Number
    K952527
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION ¿ EVALUATION A VISUAL INSPECTION OF THE RETURNED DEVICE WAS CONDUCTED. A DOCUMENT BASED INVESTIGATION WAS ALSO PERFORMED INCLUDING A REVIEW OF COMPLAINT HISTORY, THE DEVICE HISTORY RECORD, DRAWINGS, INSTRUCTIONS FOR USE, QUALITY CONTROL DATA, AND TRENDS. ONE UNOPENED PACKAGE WAS RETURNED FOR INVESTIGATION. THE RETURNED PACKAGING CONFIRMS LOT NUMBER 9060688. THE VISUAL EXAM OF THE RETURNED DEVICE NOTED BLACK PARTICLES ON THE BALLOON MATERIAL, POSSIBLY BLACK INK. A REVIEW OF THE DEVICE HISTORY RECORDS FOR LOT 9060688 RECORDS FOUND THERE WERE NO NON-CONFORMANCES. A REVIEW OF COMPLAINT HISTORY RECORDS REVEALED THIS COMPLAINT TO BE THE ONLY ONE ASSOCIATED WITH COMPLAINT LOT NUMBER 9060688. THE COMPLAINT WAS CONFIRMED BASED ON INVESTIGATION OF THE RETURNED DEVICE. THE CAUSE FOR THIS FAILURE MODE IS A MANUFACTURING ISSUE. APPROPRIATE MANUFACTURING PERSONNEL HAVE BEEN INFORMED OF THIS EVENT AND COMPLETED RETRAINING TO PREVENT SIMILAR DEVICE FAILURE IN THE FUTURE. 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). 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 THAT WHILE PREPARING FOR AN UNSPECIFIED PROCEDURE USING A BALLOON UTERINE STENT, THE END USER OPENED THE PACKAGE TO INSPECT THE DEVICE PRIOR TO USE AND FOUND AN UNKNOWN BLACK STAIN ON THE BALLOON. THIS DEVICE WAS NOT USED. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE ALLEGED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    6799 BALLOON UTERINE STENT KNA INSTRUMENT, MANUAL, SPECIALIZED OBSTETRIC-GYNECOLOGIC KNA COOK INC 9060688 00827002170803

    Patients

    Seq Age Sex Outcome Treatment
    1