BD BBL¿ TB AURAMINE M

Additional Manufacturer Narrative

THE FOLLOWING FIELD WAS UPDATED WITH CORRECTED INFORMATION: D.3. MEDICAL DEVICE MANUFACTURER: BECTON DICKINSON& CO. ¿ SPARKS, MD / 21152. H.6. INVESTIGATION SUMMARY: THE FOLLOWING SUMMARY IS IN RESPONSE TO PR (B)(4) AGAINST MATERIAL 212514, AND LOT 1089351 FOR PRECIPITATE DEFECTS. COMPONENTS ARE MIXED AND DISPENSED INTO THE APPROPRIATE CONTAINERS. AFTER QC TESTING PRODUCT IS RELEASED AND TRANSPORTED 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 PER THE BD COA 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. NO RETURNS OR PHOTOS WERE RECEIVED. THE RETENTION SAMPLE FROM THE COMPLAINT BATCH WAS EVALUATED ALONG WITH A CONTROL BATCH OF TB AURAMINE M. 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. THE PRESENCE OF THE PARTICLES IS NOT CONSIDERED A PRODUCT DEFECT FOR TB AURAMINE, AS THEY ARE EXPECTED TO BE PRESENT WITHIN THE SUSPENSION, AND ALLOWABLE PER CLAIMS ON THIS PRODUCT. CONSEQUENTLY, THIS COMPLAINT CANNOT BE CONFIRMED. BD WILL CONTINUE TO TREND FOR PRECIPITATE DEFECTS. IF YOU HAVE FURTHER QUESTIONS, PLEASE CONTACT BD TECHNICAL SERVICES. H3 OTHER TEXT : SEE H10.

Description of Event or Problem

IT WAS REPORTED THAT PRIOR TO USE WITH BD BBL¿ TB AURAMINE M 4 BOTTLES WERE DISCOVERED TO HAVE PRECIPITATES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE CUSTOMER REPORTED PRECIPITATES IN THE BOTTLES OF TB AURAMINE M STAIN THEY RECEIVED FROM LOT 1089351, EXP: 2022-04-30.

Additional Manufacturer Narrative

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

IT WAS REPORTED THAT PRIOR TO USE WITH BD BBL¿ TB AURAMINE M 4 BOTTLES WERE DISCOVERED TO HAVE PRECIPITATES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE CUSTOMER REPORTED PRECIPITATES IN THE BOTTLES OF TB AURAMINE M STAIN THEY RECEIVED FROM LOT 1089351, EXP: 2022-04-30.