BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ TB AURAMINE M

    MDR report key: 24896733 · Received April 16, 2026

    Report

    Report Number
    1119779-2026-00678
    Event Type
    Malfunction
    Date Received
    April 16, 2026
    Date of Event
    March 10, 2026
    Report Date
    May 11, 2026
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    KJK
    UDI-DI
    30382902125144
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS MEMO IS TO SUMMARIZE FINDINGS ON YOUR COMPLAINT RELATED TO BOTTLE TB AURAMINE M 250ML, CATALOG NUMBER 212514, BATCH NUMBER 5112426, COMPLAINT # (B)(4) FOR SOLUTION APPEARANCE DEFECT. BACKGROUND: COMPONENTS ARE MIXED AND DISPENSED INTO THE APPROPRIATE CONTAINERS. AFTER QC TESTING PRODUCT IS RELEASED AND TRANSPORTED TO THE DISTRIBUTION CENTER. BATCH HISTORY REVIEW: THE BATCH HISTORY RECORD REVIEW INDICATED NO DISCREPANCIES. COMPLAINT HISTORY REVIEW: THE COMPLAINT TRENDS WERE REVIEWED FOR A PERIOD COVERING 12 MONTHS. DURING THAT TIME THERE HAVE BEEN NO OTHER CONFIRMED COMPLAINTS FOR THESE ISSUES. RETURNED MATERIAL ANALYSIS: NO PHOTOS OR RETURNS WERE AVAILABLE AT THE TIME OF THE INVESTIGATION. INVESTIGATIONAL TESTING/REVIEW: ALL RELEASE TESTING WAS SATISFACTORY. SATISFACTORY APPEARANCE IS ¿YELLOW SUSPENSION¿. BY DEFINITION A SUSPENSION IS ¿A MIXTURE IN WHICH PARTICLES ARE DISPERSED THROUGHOUT THE BULK OF THE FLUID¿. IT IS ALSO DEFINED AS ¿A MIXTURE IN WHICH ALL PARTICLES OF A SUBSTANCE ARE DISPERSED THROUGHOUT A GAS OR LIQUID. IF A SUSPENSION IS LEFT UNDISTURBED, THE PARTICLES ARE LIKELY TO SETTLE TO THE BOTTOM. THE PARTICLES IN A SUSPENSION ARE LARGER THAN THOSE IN EITHER A COLLOID OR A SOLUTION¿. THE RETENTION SAMPLE FROM THE COMPLAINT BATCH NUMBER 5112426 WAS EVALUATED ALONG WITH A CONTROL BATCH OF TB AURAMINE M. THERE WAS A LARGE AMOUNT OF PARTICULATE VISIBLE IN THE RETENTION SAMPLES AS WELL AS THE CONTROL. STAINING WAS COMPLETED PER INSTRUCTIONS IN THE PRODUCT INSERT. SLIDES OF POSITIVE (M. TUBERCULOSIS ATCC 25177) AND NEGATIVE (B. SUBTILIS ATCC 6533) CONTROLS WERE EVALUATED AND GAVE SATISFACTORY STAINING RESULTS WITH THE RETENTION AND CONTROL BATCHES. THE RETENTION SAMPLE WAS COMPARABLE TO THE CONTROL. CONCLUSION: THIS COMPLAINT CANNOT BE CONFIRMED AS THE SOLUTION APPEARANCE OF RETENTION SAMPLES IS SATISFACTORY. BD WILL CONTINUE TO TREND SOLUTION APPEARANCE COMPLAINTS AND ASSESS PRODUCT INTENDED USES AGAINST REGULATORY REQUIREMENTS.

    Additional Manufacturer Narrative · 0

    E1. INITIAL REPORTER PHONE #: (B)(6). A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING ONE (1) BD BBL¿ TB AURAMINE M BOTTLE, THERE WAS PRECIPITATION PRESENT IN THE STAIN. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING ONE (1) BD BBL¿ TB AURAMINE M BOTTLE, THERE WAS PRECIPITATION PRESENT IN THE STAIN. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    111982 BD BBL¿ TB AURAMINE M AURAMINE O KJK BECTON DICKINSON & CO. (SPARKS) 5112426 30382902125144

    Patients

    Seq Age Sex Outcome Treatment
    1