BD BBL¿ TB BRILLIANT GREEN K
Received Feb 20, 2025 · Event occurred Jan 14, 2025
Report 1119779-2025-00101 · MDR key 21427237
Device
Generic name
Brilliant Green
Manufacturer
Becton Dickinson & Co. (sparks)Catalog number
212523
Lot number
4171966
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
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
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
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.
Additional Manufacturer Narrative
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.