BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THE BETTER BLADDER

    MDR report key: 11835453 · Received May 17, 2021

    Report

    Report Number
    1000522036-2021-00001
    Event Type
    Malfunction
    Date Received
    May 17, 2021
    Date of Event
    April 16, 2021
    Report Date
    May 15, 2021
    Manufacturer
    CIRCULATORY TECHNOLOGY, INC.
    Product Code
    DTN
    UDI-DI
    00851997007004
    PMA / PMN Number
    K981284
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ALL BETTER BLADDER UNITS ARE VISUALLY INSPECTED AND TESTED DURING MANUFACTURING PRIOR TO RELEASE. TESTING INCLUDES A PULL TEST AND LEAK TESTING TO VERIFY A HERMETIC SEAL. THE UNITS MET ALL ACCEPTANCE CRITERIA. EVALUATION OF RETURNED PRODUCT AND RETAIN SAMPLES CONFIRMED THE PRODUCT COMPLAINT. THE UNITS WERE FOUND TO HAVE INSUFFICIENT ADHESIVE APPLIED DURING THE ASSEMBLY RESULTING IN AN INEFFECTIVE SEAL BETWEEN THE PIGTAIL AND THE HOUSING PORT.. THIS ISSUE IS ISOLATED TO ONE MANUFACTURING LOT, LOT 5290-201001. THIS MANUFACTURING LOT WAS RECALLED ON 4/27/2021. ROOT CAUSE: INSUFFICIENT ADHESIVE. CORRECTION/CONTAINMENT: RECALL AND REPLACE. CORRECTIVE ACTIONS: AN ADDITIONAL STEP IS BEING INCORPORATED INTO THE ASSEMBLY OF THE BB14 AND BBB38. HENCEFORTH, ADDITIONAL ADHESIVE WILL BE APPLIED TO THE EXTERNAL JUNCTURE BETWEEN THE PIGTAIL AND THE HOUSING PORT, THE ADHESIVE TO COVER AT LEAST 1/8" ALONG THE ENTIRE PERIPHERY OF THE EXTERNAL WALL OF HOUSING AND AT LEAST 1/8" ALONG THE ENTIRE PERIPHERY OF THE OD OF THE PIGTAIL. THIS ENHANCEMENT WOULD ASSURE MORE ADHESIVE, A POST ASSEMBLY VISUAL OBSERVATION OF THE ADHESIVE AND THE ADDITIONAL SEALING THAT HAS PROVED EFFECTIVE FOR THE SEAL BETWEEN THE LARGE TUBE AND THE HOUSING, A SEAL THAT HAS THAT BEAD. PREVENTIVE ACTIONS: ADD PULL GAGE WITH FORCE REQUIREMENT TO THE PROCESS SPECIFICATION. ADD AN IN-PROCESS AND FINISHED PRODUCT VISUAL INSPECTION OF THE GLUE BEAD AROUND THE PIGTAIL.

    Description of Event or Problem · 1

    ON 4/16/2021, CTI WAS NOTIFIED BY THE ECMO COORDINATOR THAT WHILE CONDUCTING THE REQUIRED LEAK TESTS, A BB14 UNIT LEAKED. PLACING THE UNIT UNDER WATER WITH IT ¼" TUBES CLAMPED OFF AND PRESSURE APPLIED TO THE PIGTAIL SHOWED BUBBLES ESCAPING FROM THE JUNCTURE BETWEEN THE HOUSING AND PIGTAIL. WHEN WIPING THE PIGTAIL OFF, IT DISCONNECTED FROM THE HOUSING. THE PRODUCT WAS IDENTIFIED AS LOT # 5290-201001. THERE WAS NO PATIENT INVOLVED AS THE LEAK OCCURED PRIOR TO USE OF THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    735368 THE BETTER BLADDER BETTER BLADDER DTN CIRCULATORY TECHNOLOGY, INC. BB14 5290-201001 00851997007004

    Patients

    Seq Age Sex Outcome Treatment
    1 Other