BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ TB BRILLIANT GREEN K

    MDR report key: 21427237 · Received February 20, 2025

    Report

    Report Number
    1119779-2025-00101
    Event Type
    Malfunction
    Date Received
    February 20, 2025
    Date of Event
    January 14, 2025
    Report Date
    August 14, 2025
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    KJO
    UDI-DI
    30382902125236
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: COMPONENTS ARE MIXED AND DISPENSED INTO CONTAINERS. FOLLOWING QC RELEASE, AND BASED UPON INVENTORY DEMAND, FINAL PACKAGING OPERATIONS OCCUR FOLLOWED BY TRANSPORT TO THE DISTRIBUTION CENTER. THE COMPLAINT INVESTIGATION INCLUDED A REVIEW OF THE BATCH HISTORY RECORD FOR TB BRILLIANT GREEN K. THE BATCH HISTORY RECORD REVIEWS INDICATED NO DISCREPANCIES. ALL RELEASE TESTING WAS SATISFACTORY. COMPLAINT TRENDS WERE REVIEWED FOR A PERIOD COVERING 12 MONTHS. DURING THAT TIME THERE HAVE BEEN NO CONFIRMED COMPLAINTS FOR THE DEFECT IN QUESTION. BD BBL¿ TB STAIN KITS (TB BRILLIANT GREEN K IS ONE OF THE COMPONENTS) ARE USED TO MANUALLY STAIN SMEARS PREPARED FROM SPECIMENS AND CULTURES SUSPECTED OF CONTAINING MYCOBACTERIA, ESPECIALLY MYCOBACTERIUM TUBERCULOSIS, FOR QUALITATIVE EARLY PRESUMPTIVE DIAGNOSIS OF MYCOBACTERIAL INFECTION AND CHARACTERIZATION OF BACTERIAL ISOLATES. SLIDES OF POSITIVE (M. TUBERCULOSIS ATCC 25177) AND NEGATIVE (B. SUBTILIS ATCC 6533) CONTROLS WERE EVALUATED AND GAVE SATISFACTORY STAINING RESULTS AT RELEASE OF THE PRODUCT. ONE PHOTO WAS ATTACHED IN LIEU OF RETURN. THE PHOTO DEPICTS A MICROSCOPE VIEW OF BACTERIA RODS STAINED RED AND BLUE-GREEN COLORS. THERE IS NO INFORMATION ABOUT THE NAME OR ATCC NUMBERS FOR THE STAINED CULTURES. FROM CUSTOMER'S RESPONSE: ¿WE USED AFB QC SLIDES WHICH GAVE EXPECTED RESULTS.¿ THE CUSTOMER WAS EXPECTING TO OBTAIN MODIFIED ACID STAIN POSITIVE RESULTS FOR THEIR SAMPLE. BASED ON THE LIMITATIONS OF THE PROCEDURE AND RELEASE SPECIFICATIONS FOR THE PRODUCT, WE ARE UNABLE TO FURTHER REPLICATE THE CUSTOMER¿S APPLICATION WITH THIS PRODUCT. THIS COMPLAINT CANNOT BE CONFIRMED. BD WILL CONTINUE TO TREND ON PERFORMANCE ISSUES.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD BBL¿ TB BRILLIANT GREEN K, ONE (1) PATIENT SAMPLE CONTAINED BRANCHING ORGANISMS THAT WAS STAINING KINYOUN POSITIVE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD BBL¿ TB BRILLIANT GREEN K, ONE (1) PATIENT SAMPLE CONTAINED BRANCHING ORGANISMS THAT WAS STAINING KINYOUN POSITIVE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    417154 BD BBL¿ TB BRILLIANT GREEN K BRILLIANT GREEN KJO BECTON DICKINSON & CO. (SPARKS) 4171966 30382902125236

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown