BD BBL¿ CHROMAGAR¿ CANDIDA

Description of Event or Problem

IT WAS REPORTED WHILE USING BD BBL¿ CHROMAGAR¿ CANDIDA, THERE WAS A FALSE RESULT DUE TO CONTAMINATION. THERE WAS NO REPORT OF PATIENT IMPACT.

Additional Manufacturer Narrative

E1. INITIAL REPORTER ADDRESS: (B)(6). INVESTIGATION SUMMARY: DURING MANUFACTURING OF MATERIAL 254093, MEDIA IS FORMULATED AND SENT THROUGH A HIGH TEMPERATURE SHORT TIME STERILIZER TO REMOVE BIOBURDEN. THE PETRI DISHES ARE SUBJECTED TO UV RADIATION TO DECREASE BIOBURDEN. THE PETRI DISHES ARE FILLED IN A POSITIVE PRESSURE HEPA FILTERED ENVIRONMENT. THE FILLED PLATES ARE COOLED AND IMMEDIATELY WRAPPED INTO SLEEVES TO DECREASE THE INTRODUCTION OF MICROBES. SLEEVES ARE THEN PACKAGED INTO CARTONS AND THEN TRANSFERRED TO A REFRIGERATED TRUCK (2 TO 8 DEGREES C) FOR SHIPMENT TO THE DISTRIBUTOR. BD DISTRIBUTORS ARE PROVIDED WITH THE STORAGE GUIDELINES FOR THE SHIPPING AND HANDLING OF BD MEDIA OF 2 TO 8 DEGREES C IN A DARK PLACE. THE BATCH HISTORY RECORD FOR BATCH 4218243 WAS SATISFACTORY AND NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND INSPECTION. THE RELEASE TESTING THAT IS PERFORMED ON THIS PRODUCT DOES INCLUDE BIOBURDEN TESTING. A SAMPLE OF PLATES ARE INCUBATED AT 25 DEGREES C AND AT 35 DEGREES C FOR APPROXIMATELY 72 HOURS. ALL BIOBURDEN TESTING PERFORMED ON THIS BATCH WAS SATISFACTORY PER BD INTERNAL PROCEDURES. AFFECTED PRODUCT DOES NOT HAVE ANY STERILITY CLAIMS; THE PRODUCT IS TESTED FOR BIOBURDEN PRIOR TO RELEASE TO ENSURE THAT IT CONFORMS TO PRODUCT SPECIFICATIONS. HOWEVER, THIS DOES NOT ENSURE THAT THE END-USER WILL NOT RECEIVE A CONTAMINATED PLATE. THE COMPLAINT HISTORY WAS REVIEWED, AND THERE WAS ONE OTHER COMPLAINT FOR CONTAMINATION THAT HAS BEEN TAKEN ON BATCH 4218243. NO RETENTION SAMPLES WERE AVAILABLE OF INVESTIGATION OF THIS COMPLAINT. TWO PICTURES WERE RECEIVED FOR INVESTIGATION OF THIS COMPLAINT. MATERIAL AND BATCH WERE ABLE TO BE CONFIRMED. DEFECT WAS CONFIRMED. NO RETURN SAMPLES WERE RECEIVED FOR INVESTIGATION OF THIS COMPLAINT. THIS COMPLAINT CAN BE CONFIRMED. NO COMPLAINT TRENDS FOR THIS DEFECT HAVE BEEN IDENTIFIED FOR THIS PRODUCT; NO ACTIONS ARE INDICATED AT THIS TIME. BD WILL CONTINUE TO TREND COMPLAINTS FOR CONTAMINATION. THIS MDR IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW OF RECORDS DATING (B)(6) 2023-2025, UNDER CAPA 11910483