BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ TB CARBOLFUCHSIN KF

    MDR report key: 21098659 · Received January 7, 2025

    Report

    Report Number
    1119779-2024-01058
    Event Type
    Malfunction
    Date Received
    January 7, 2025
    Date of Event
    November 1, 2024
    Report Date
    February 27, 2025
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    ICL
    UDI-DI
    30382902125182
    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: THIS MEMO IS TO SUMMARIZE FINDINGS ON YOUR COMPLAINT RELATED TO BOTTLE TB CARBOLFUCHSIN KF 250 ML, CATALOG NUMBER: 212518, BATCH NUMBER: 4100006, AND COMPLAINT NUMBER: (B)(4) FOR PERFORMANCE. 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 CARBOLFUCHSIN KF. 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. THREE PHOTOS WERE ATTACHED IN LIEU OF RETURN. ALL PHOTOS DEPICT A DIFFERENT MICROSCOPE VIEW OF ACID-FAST STAIN BACTERIA. BD BBL¿ TB STAIN KITS 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. FROM CUSTOMER'S RESPONSE: ¿AFB QC SLIDES WERE USED AND PRODUCED EXPECTED RESULTS. POSITIVE CONTROL SLIDE HAD PINK/RED ACID-FAST BACILLI. NEGATIVE CONTROL SLIDE HAD GREENISH-BLUE BACKGROUND¿. THE ORGANISM DESCRIBED IN THE COMPLAINT REPORT IS NOCARDIA. BD DOES NOT HAVE ESTABLISHED RELEASE REQUIREMENTS OR PERFORMANCE DATA FOR STAINING NOCARDIA. 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

    REPORT 1 OF 3: IT WAS REPORTED WHILE USING BD BBL¿ TB CARBOLFUCHSIN KF, NOCARDIA STAINED AS FULL ACID FAST ON A PATIENT SAMPLE. A PRELIMINARY RESULT WAS REPORTED AS AN ACID-FAST ORGANISM, AND THEN UPON FURTHER REVIEW RESULTS WERE CORRECTED. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

    Description of Event or Problem · 0

    REPORT 1 OF 3: IT WAS REPORTED WHILE USING BD BBL¿ TB CARBOLFUCHSIN KF, NOCARDIA STAINED AS FULL ACID FAST ON A PATIENT SAMPLE. A PRELIMINARY RESULT WAS REPORTED AS AN ACID FAST ORGANISM, AND THEN UPON FURTHER REVIEW RESULTS WERE CORRECTED. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    882863 BD BBL¿ TB CARBOLFUCHSIN KF CARBOL FUCHSIN ICL BECTON DICKINSON & CO. (SPARKS) 4100006 30382902125182

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown