BD BBL¿ MARTIN-LEWIS AGAR

Additional Manufacturer Narrative

INVESTIGATION SUMMARY: IT WAS REPORTED THAT NORMALLY PROTEUS SPP ARE INHIBITED FOR GROWTH ON THIS MEDIUM DUE TO THE ANTIBIOTICS THAT ARE INCLUDED INTO THE MEDIUM CFR PACKAGE INSERT. WITH THIS LOT THE OVERGROWTH OF PROTEUS SPP IS NOTICED. THE COMPLAINT HISTORY WAS REVIEWED, AND NO SIMILAR COMPLAINTS WERE REPORTED FOR THE AFFECTED CATALOG NUMBER. A TREND WAS NOT IDENTIFIED. THE BATCH HISTORY REVIEW DID NOT INDICATE ANY DISCREPANCIES. ALL RELEASE TESTING WAS SATISFACTORY, AND NO DEVIATIONS WERE OBSERVED. RETAIN SAMPLES WERE ANALYZED IN A PERFORMANCE TEST USING PROTEUS MIRABILIS ATCC 43071, PROTEUS MIRABILIS ATCC 14153 AND PROTEUS MIRABILIS ATCC 12453. NO DEVIATION WAS DETECTED, AND GROWTH WAS STILL INHIBITED AFTER 48 HOURS AT 35-37°C IN CO2 ATMOSPHERE INCUBATION. NO RETURN SAMPLES WERE PROVIDED BY THE CUSTOMER FOR ANALYSIS. A PICTURE WAS SHARED SHOWING A PLATE WITH GROWTH OF BACTERIA. BASED UPON OUR INVESTIGATION, WE HAVE EXCLUDED ANY SYSTEMATIC FAILURE IN OUR MANUFACTURING PROCESS. ALL THE RELEASE TESTING WAS SATISFACTORY AND ADDITIONALLY, THE RETEST PERFORMED ON THE RETAIN SAMPLES WITH PROTEUS MIRABILIS ATCC 43071, PROTEUS MIRABILIS ATCC 14153 AND PROTEUS MIRABILIS ATCC 12453 WAS SATISFACTORY. SINCE NO TREND WAS IDENTIFIED AND NO PROCESS DEVIATION COULD BE DETECTED, FURTHER ACTIONS ARE NOT INDICATED AT THIS POINT. BASED ON THE RESULTS OF THE INVESTIGATION AND THE EVALUATION OF RETAIN SAMPLES WE CANNOT CONFIRM THIS COMPLAINT. HOWEVER, BD WILL CONTINUE MONITORING INCOMING COMPLAINT WITH SIMILAR FAILURE MODE. THIS MDR IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW OF RECORDS DATING APRIL 2023-2025, UNDER CAPA 11910483.

Description of Event or Problem

IT WAS REPORTED WHILE USING BD BBL¿ MARTIN-LEWIS AGAR, THE MEDIA FAILED TO INHIBIT GROWTH OF PROTEUS SPECIES. THERE WAS NO REPORT OF PATIENT IMPACT.