BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    THE BETTER BLADDER

    MDR report key: 11891459 · Received May 26, 2021

    Report

    Report Number
    1000522036-2021-00003
    Event Type
    Malfunction
    Date Received
    May 26, 2021
    Date of Event
    April 26, 2021
    Report Date
    May 26, 2021
    Manufacturer
    CIRCULATORY TECHNOLOGY, INC.
    Product Code
    DTN
    UDI-DI
    00851997007004
    PMA / PMN Number
    K981284
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 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.. AT THE TIME OF THIS REPORT, THIS ISSUE HAS BEEN DETECTED IN TWO MANUFACTURING LOTS, LOT 5290-201001 AND 5290-210401. BOTH LOTS HAVE BEEN RECALLED. 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 4/26/2021, CTI WAS NOTIFIED THAT THE PIGTAIL OF BB14 (LOT # 5290-201001) IN A WET CIRCUIT READIED FOR CLINICAL USE DISLODGED FROM THE HOUSING WHEN PULLED ON. NO PATIENT WAS INVOLVED. THE COMPLAINANT STATED THAT THE FACILITY DID NOT LEAK TEST PRIOR TO USE, AS REQUIRED IN THE IFU. ON 5/17/21 THE COMPLAINANT CALLED AND INFORMED CTI THAT AN ADDITIONAL UNIT FROM ANOTHER LOT, LOT 5290-210401, FAILED THE REQUIRED LEAK TEST PRIOR TO USE. THIS UNIT WAS NOT USED ON A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    787514 THE BETTER BLADDER BETTER BLADDER DTN CIRCULATORY TECHNOLOGY, INC. BB14 5290-201001, 5290-210401 00851997007004

    Patients

    Seq Age Sex Outcome Treatment
    1 Other