BD BBL¿ TB AURAMINE M

Additional Manufacturer Narrative

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

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.

Additional Manufacturer Narrative

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.

Description of Event or Problem

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.