BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THE BIGGER BETTER BLADDER

    MDR report key: 9373246 · Received November 25, 2019

    Report

    Report Number
    1000522036-2019-00002
    Event Type
    Malfunction
    Date Received
    November 25, 2019
    Date of Event
    October 14, 2019
    Report Date
    November 13, 2019
    Manufacturer
    CIRCULATORY TECHNOLOGY, INC
    Product Code
    DTN
    UDI-DI
    00851997007004
    PMA / PMN Number
    K981284
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ALL BETTER BLADDER PRODUCTS ARE VISUALLY INSPECTED AND TESTED DURING MANUFACTURING. LOTS 180307 AND 190603 WERE MANUFACTURED BY CONTRACT MANUFACTURER, DG MEDICAL, ON 3/27/2018 AND 6/13/2019, RESPECTIVELY. ALL UNITS WERE SUCCESSFULLY TESTED AND THERE WERE NO NONCONFORMITIES OR DEVIATIONS NOTED DURING MANUFACTURING. TESTING OF THE RETURNED UNITS FOUND THAT THE UNITS WERE FULLY FUNCTIONAL, ALTHOUGH CTI DOES ACKNOWLEDGE MINOR CRINKLING, WHICH IS CONSIDERED A COSMETIC DEFECT. CTI INTENDS TO IMPLEMENT CORRECTIVE ACTIONS TO MINIMIZE CRINKLING DURING THE MANUFACTURING PROCESS AND UPDATE THE IFU TO DENOTE THAT CRINKLING DOES NOT ADVERSELY AFFECT THE OPERATION OF THE UNIT.

    Description of Event or Problem · 1

    THE END USER REPORTED THAT TWO BETTER-BLADDERS HAD BALLOONS WITH CRINKLING AND WERE NOT USABLE. THEY TRIED TO "REINFLATE" THEM UNSUCCESSFULLY. THE CRINKLES ARE MINOR AND HARD TO PICK UP IN A PHOTO (DO NOT SHOW WELL). THEY BECAME MORE EVIDENT WHEN WE PUT THEM ON 2 DIFFERENT PATIENTS AND HAD TO REMOVE THEM EMERGENTLY. THOSE WERE THROWN AWAY. FOUND IN OUR STOCK 4 BB14 AND 2 BBB38.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1168333 THE BIGGER BETTER BLADDER THE BIGGER BETTER BLADDER DTN CIRCULATORY TECHNOLOGY, INC BB14, BBB38 5290U20735, 5300T20148 00851997007004

    Patients

    Seq Age Sex Outcome Treatment
    1