BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THE BIGGER BETTER BLADDER

    MDR report key: 9879086 · Received March 25, 2020

    Report

    Report Number
    1000522036-2020-00001
    Event Type
    Malfunction
    Date Received
    March 25, 2020
    Date of Event
    February 17, 2020
    Report Date
    March 24, 2020
    Manufacturer
    CIRCULATORY TECHNOLOGY, INC.
    Product Code
    DTN
    UDI-DI
    00851997007011
    PMA / PMN Number
    K981284
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    AS PREVIOUSLY STATED, ALL BETTER BLADDER PRODUCTS ARE VISUALLY INSPECTED AND TESTED DURING MANUFACTURING. THE LOT WAS MANUFACTURED BY CONTRACT MANUFACTURER, DG MEDICAL, AND MET ALL ACCEPTANCE CRITERIA. TWO ADDITIONAL UNITS FROM THE SAME MANUFACTURING LOT WERE TESTED AND FOUND ACCEPTABLE. THE USER STATES THAT THE BIGGER BETTER-BLADDER (BBB38) FAILED DUE TO THE BLADDER COLLAPSING. THIS PRODUCT LOT WAS MANUFACTURED WITH AN IMPROVED BOND BETWEEN THE TUBING AND THE HOUSING AND THIS IS THE FIRST COMPLAINT OF A COLLAPSING BBB38. UNFORTUNATELY, THE UNITS WERE NOT RETURNED TO THE CTI AND HENCE IT WAS NOT POSSIBLE TO VALIDATE THE FAILURE NOR DETERMINE THE CAUSE OF THE FAILURE. POTENTIAL ROOT CAUSE: THE COLLAPSE MAY HAVE BEEN DUE TO A POOR CONNECTION ANYWHERE BETWEEN THE PIGTAIL AND THE PRESSURE TRANSDUCER (E.G. NUMEROUS STOPCOCKS AND NUMEROUS LUER FITTINGS). THIS IS A USER ERROR AND COULD NOT BE CONFIRMED. CONCLUSION: THE PRODUCT CONCERN COULD NOT BE CONFIRMED BY CTI. THERE HAVE BEEN NO OTHER COMPLAINTS FOR THIS MANUFACTURING LOT, OR FOR THIS FAILURE MODE SINCE IMPLEMENTATION OF CORRECTIVE ACTION.

    Description of Event or Problem · 1

    ON 2/24/2020, HOSPITAL NOTIFIED MANUFACTURER THAT TWO BIGGER BETTER-BLADDERS, MODEL BBB38, BEGAN TO COLLAPSE WITHIN 24 HOURS OF CLINICAL USE. THE FIRST BBB38 STARTED TO COLLAPSE UPON ECLS INITIATION ON (B)(6) 2020. THE 2ND COLLAPSED 12 HRS AFTER A CIRCUIT CHANGE ON (B)(6) 2020. THEY KEPT COLLAPSING AND WERE CHANGED WITH A BBB38 FROM ANOTHER LOT. THE PRODUCTS WERE USED ON THE SAME PATIENT. THE UNITS WERE REPLACED AND THERE WAS NO HARM OR ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    345247 THE BIGGER BETTER BLADDER BIGGER BETTER BLADDER (BBB38) DTN CIRCULATORY TECHNOLOGY, INC. BBB38 5300-T20265 00851997007011

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Other