BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THE BETTER BLADDER

    MDR report key: 10323534 · Received July 24, 2020

    Report

    Report Number
    1000522036-2020-00002
    Event Type
    Malfunction
    Date Received
    July 24, 2020
    Date of Event
    June 26, 2020
    Report Date
    July 24, 2020
    Manufacturer
    CIRCULATORY TECHNOLOGY, INC.
    Product Code
    DTN
    UDI-DI
    00851997007041
    PMA / PMN Number
    K981284
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY REPORTED THREE COLLAPSED UNITS, MODEL BB14. ALL UNITS WERE FROM THE SAME MANUFACTURING LOT. ALL BETTER BLADDER UNITS ARE VISUALLY INSPECTED AND TESTED DURING MANUFACTURING PRIOR TO RELEASE. TESTING INCLUDES LEAK TESTING TO VERIFY A HERMETIC SEAL. THE UNITS MET ALL ACCEPTANCE CRITERIA. EVALUATION OF THE TWO RETURNED UNITS FOUND ONE LEAKING UNIT LEAKING AT THE BASE OF THE HOUSING PORT ACCOMMODATING THE PIGTAIL TUBING. THIS IS CONSIDERED AN ISOLATED EVENT WITH THE FOLLOWING RATIONALE: UNITS ARE MANUFACTURED INDIVIDUALLY AND THERE HAVE BEEN NO OTHER COMPLAINTS RECEIVED FOR THIS MANUFACTURING LOT. THIS IS THE FIRST COMPLAINT FOR A LEAKING UNIT SINCE (B)(6) 2017. THE DEFECT RATE FOR THIS FAILURE MODE SINCE NOVEMBER 2017 IS LESS THAN (B)(4). THE OTHER UNIT TESTED MET ALL ACCEPTANCE CRITERIA. CONCLUSION: THE COMPLAINT WAS CONFIRMED FOR UNIT 1, BUT NOT FOR UNITS 2 AND 3. THE ROOT CAUSE FOR UNIT 1 HAS NOT YET BEEN DETERMINED, ALTHOUGH IT IS DEEMED AN ISOLATED EVENT. THE COMPLAINT FOR UNITS 2 AND 3 COULD NOT BE CONFIRMED. THE MOST PROBABLE ROOT CAUSE IS A POOR CONNECTION ANYWHERE BETWEEN THE PIGTAIL AND THE PRESSURE TRANSDUCER. THIS IS CONSIDERED AN OPERATOR ERROR BUT CANNOT BE CONFIRMED BY THE MANUFACTURER.

    Description of Event or Problem · 1

    ON (B)(6) 2020, A HOSPITAL NOTIFIED THE MANUFACTURER THAT THREE BETTER-BLADDERS, MODEL BB14, BEGAN TO COLLAPSE WITHIN 24 HOURS OF CLINICAL USE. THE UNITS WERE IMMEDIATELY REPLACED AND NO HARM OR ADVERSE EFFECT TO THE PATIENT WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    783057 THE BETTER BLADDER BETTER BLADDER DTN CIRCULATORY TECHNOLOGY, INC. BB14 5290-U21230 00851997007041

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Other