BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL TB AURAMINE M

    MDR report key: 19975506 · Received August 13, 2024

    Report

    Report Number
    1119779-2024-00594
    Event Type
    Malfunction
    Date Received
    August 13, 2024
    Date of Event
    July 15, 2024
    Report Date
    January 8, 2025
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    KJK
    UDI-DI
    00382902125143
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: THIS MEMO IS TO SUMMARIZE FINDINGS ON YOUR COMPLAINT RELATED TO BOTTLE TB AURAMINE M 250ML, CATALOG NUMBER 212514, BATCH# 3241141 AND COMPLAINT #(B)(4). FOR APPEARANCE. COMPONENTS ARE MIXED AND DISPENSED INTO CONTAINERS. FOLLOWING QC RELEASE, AND BASED UPON INVENTORY DEMAND, FINAL PACKAGING OPERATIONS OCCUR, WHICH INCLUDE DISPENSING INTO AND LABELING OF FINAL CONFIGURATIONS, FOLLOWED BY TRANSPORT TO THE DISTRIBUTION CENTER. THE COMPLAINT INVESTIGATION INCLUDED A REVIEW OF THE BATCH HISTORY RECORD TB AURAMINE M. THE BATCH HISTORY RECORD REVIEW INDICATED NO DISCREPANCIES. 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¿. COMPLAINT TRENDS WERE REVIEWED FOR A PERIOD COVERING 12 MONTHS. DURING THAT TIME THERE HAVE BEEN NO CONFIRMED COMPLAINTS FOR THE DEFECT IN QUESTION FOR THIS PRODUCT. THREE PHOTOS WERE ATTACHED TO THE COMPLAINT. THE FIRST PHOTO DEPICTS ONE BOTTLE WITH YELLOW SOLUTION AND LABEL FOR TB AURAMINE M PART # 212514 AND LOT # 3241141, EXPIRATION DATE 2024/0/31. THE SECOND PHOTO DEPICTS THE BOTTOM OF THE BOTTLE WITH YELLOW SUSPENSION. THE THIRD PHOTO DEPICTS THE BOTTLE TILTED DOWN AND AWAY FROM THE CAMERA WITH PARTICLES STUCK TO THE BOTTOM OF THE BOTTLE. THE RETENTION SAMPLE FROM THE COMPLAINT BATCH 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. THE RETENTION SAMPLE WAS COMPARABLE TO THE CONTROL. THE PRECIPITATE IN QUESTION IS INHERENT TO THE STAIN AND DOES NOT AFFECT THE PERFORMANCE OF THE STAIN. THE COMPLAINT IS NOT CONFIRMED. BD WILL CONTINUE TO TREND ON THIS ISSUE. IF YOU HAVE FURTHER QUESTIONS, PLEASE CONTACT TECHNICAL SERVICES.

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED BEFORE USE OF BD BBL TB AURAMINE M, PRECIPITATION/YELLOW PIGMENT WAS OBSERVED AT THE BOTTOM OF THE BOTTLE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED BEFORE USE OF BD BBL TB AURAMINE M, PRECIPITATION/YELLOW PIGMENT WAS OBSERVED AT THE BOTTOM OF THE BOTTLE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1094964 BD BBL TB AURAMINE M AURAMINE O KJK BECTON DICKINSON & CO. (SPARKS) 3241141 00382902125143

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown