BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT

Additional Manufacturer Narrative

INITIAL REPORTER FIRST NAME: (B)(6). INVESTIGATION SUMMARY: MGIT 960 SUPPLEMENT KIT BATCH 2188242 IS COMPOSED OF MGIT PANTA BATCH 2188226 AND MGIT 960 GROWTH SUPPLEMENT BATCH 2188233. THE BATCH HISTORY RECORD REVIEW FOR MGIT 960 SUPPLEMENT KIT BATCH 2188242 WAS SATISFACTORY. NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND THE ONLY COMPLAINTS HAVE BEEN TAKEN ON THIS KIT BATCH IS FROM ONE CUSTOMER. MGIT PANTA IS MANUFACTURED BY REHYDRATING COMPONENTS IN USP PURIFIED WATER AND MIXED INTO A HOMOGENOUS SOLUTION. THE SOLUTION IS THEN STERILE FILTERED, DISPENSED INTO VIALS AND STOPPERED BY MACHINE. THE VIALS ARE LYOPHILIZED, AND CRIMP CAPS ARE APPLIED PER STANDARD OPERATING PROCEDURES (SOP). MGIT 960 GROWTH SUPPLEMENT IS MANUFACTURED BY REHYDRATING THE MEDIA COMPONENTS WITH USP PURIFIED WATER AND MIXED UNTIL A HOMOGENEOUS SOLUTION IS OBTAINED. THE SOLUTION IS THEN STERILE FILTERED AND DISPENSED INTO VIALS; STOPPERS ARE MANUALLY PLACED IN THE VIAL OPENING; SEPTUM CAPS ARE MANUALLY PLACED ON TOP OF THE STOPPER AND THEN MECHANICALLY CRIMPED PER SOP. SIX MGIT PANTA VIALS ARE THEN MANUALLY PACKAGED WITH SIX MGIT GROWTH SUPPLEMENT VIALS TO MAKE A MGIT 960 SUPPLEMENT KIT (MATERIAL 245124). THE COMPONENTS OF KIT BATCH 2188242 WERE REVIEWED AND ALL BATCH HISTORY RECORDS WERE SATISFACTORY AT TIME OF RELEASE PER INTERNAL PROCEDURES. PERFORMANCE OF EACH KIT COMPONENT WAS SATISFACTORY PER PROCEDURES. RETENTION SAMPLES WERE INSPECTED FOR SUPPLEMENT BATCH 2188233 (6 VIALS) AND PANTA BATCH 2188226 (10 VIALS) AND NO MEDIA DEFECTS WERE OBSERVED IN ANY OF THESE RETENTION SAMPLES INSPECTED. FOR FURTHER INVESTIGATION TWO PANTA VIALS FROM BATCH 2188226 WERE RECONSTITUTED WITH TWO GROWTH SUPPLEMENT VIALS FROM BATCH 2188233. ONE PANTA VIAL RECONSTITUTED WITH GROWTH SUPPLEMENT (REMAINING SUPPLEMENT INSIDE THE SUPPLEMENT VIAL WAS ALSO INCUBATED) WAS PLACED INTO 20-25-DEGREES CELSIUS INCUBATOR; AND ONE PANTA VIAL RECONSTITUTED WITH GROWTH SUPPLEMENT (REMAINING SUPPLEMENT INSIDE OF THE SUPPLEMENT VIAL WAS ALSO INCUBATED) WAS PLACED INTO 33-37-DEGREES CELSIUS INCUBATOR. AT THE END OF A FOURTEEN-DAY INCUBATION PERIOD NO MICROBIAL GROWTH WAS OBSERVED IN 4/4 INCUBATED RETENTION VIALS NO RETURNS WERE RECEIVED TO ASSIST WITH THE INVESTIGATION. THIS COMPLAINT CANNOT BE CONFIRMED FROM PHOTOS FROM A GRAM STAIN. BD WILL CONTINUE TO TREND COMPLAINTS FOR CONTAMINATION DEFECTS. 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 BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT, THERE WAS A FALSE RESULT DUE TO CONTAMINATION. THERE WAS NO REPORT OF PATIENT IMPACT.