BD RODAC SNAP LID TRYPTICASE SOY AGAR (TSA) WITH LECITHIN & POLYSORBATE

Additional Manufacturer Narrative

THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 2021-01-27. INVESTIGATION SUMMARY: THIS MEMO IS TO SUMMARIZE FINDINGS REGARDING THE COMPLAINT RELATED TO CATALOG NUMBER 215276, PLATE STER TSA LP80 RODAC SNAP 100 EA, BATCH NUMBER 0274702 AND COMPLAINT (B)(4) FOR CONTAMINATION. MATERIAL 215276 IS MANUFACTURED BY REHYDRATING THE DEHYDRATED CULTURE MEDIA (DCM) WITH USP PURIFIED WATER. THE MEDIA IS THEN PROCESSED THROUGH A HIGH TEMPERATURE SHORT TIME STERILIZER TO REMOVE BIOBURDEN AND IS ASEPTICALLY DISPENSED DIRECTLY INTO PETRI DISHES. THE PETRI DISHES ARE THEN SEALED INTO CLEAN SLEEVES AND BOXED. PERSONNEL WORKING IN THE FILLING AREA ARE REQUIRED TO WEAR FULL BODY JUMPSUITS, HOODS, BOOTS, MASKS AND GLOVES. THE FILLED PLATES ARE COOLED AND IMMEDIATELY WRAPPED TO DECREASE THE INTRODUCTION OF MICROBES. DISPENSING AND SLEEVING ARE COMPLETED WITHIN AN ISO CERTIFIED ENVIRONMENT. SLEEVED PLATES ARE LOADED INTO CARTONS AND THEN CARTONS ARE TRANSFERRED TO A REFRIGERATED TRUCK (2 TO 8 DEGREES C) FOR SHIPMENT TO THE IRRADIATOR, PRODUCT IS THEN SHIPPED TO BD CUSTOMERS AND DISTRIBUTORS VIA REFRIGERATED TRUCK. BD DISTRIBUTORS ARE PROVIDED WITH THE STORAGE GUIDELINES FOR THE SHIPPING AND HANDLING OF BD MEDIA 2 TO 8 DEGREES C IN A DARK PLACE. THE BATCH HISTORY RECORD FOR BATCH 0274702 WAS SATISFACTORY AND NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND INSPECTION. THE RELEASE TESTING THAT IS PERFORMED ON THIS PRODUCT WAS SATISFACTORY PER BD INTERNAL PROCEDURES. REVIEW OF PROCESSING AND IRRADIATION RECORDS INDICATES THE PROCESSING AND GAMMA IRRADIATION DOSE WERE WITHIN BD SPECIFIED PARAMETERS. ENVIRONMENTAL MONITORING RESULTS FOR THIS MANUFACTURING PERIOD WERE WITHIN BD GUIDELINES. BD STERILE PACK PREPARED PLATED MEDIA PRODUCTS HAVE BEEN VALIDATED TO A STERILITY ASSURANCE LEVEL (SAL) OF 10^-6 USING THE AMERICAN NATIONAL STANDARD ANSI/AAMI/ISO 11137-1994, STERILIZATION OF HEALTH CARE PRODUCTS-REQUIREMENTS FOR VALIDATION AND ROUTINE CONTROL-RADIATION STERILIZATION DOSE SETTING METHOD 2A AS A GUIDELINE. AS PART OF THE SAL CLAIM, THE IDENTIFIED PROCESSES AND MONITORING RESULTS ARE REVIEWED FOR CONFORMANCE TO PREDETERMINED VALIDATION CRITERIA AND PRODUCT SPECIFICATIONS, INCLUDING CONFIRMATION THAT EACH PRODUCT BATCH WAS IRRADIATED WITHIN BD VALIDATED DOSE RANGE. IF ALL SPECIFICATIONS ARE MET, THE PRODUCT BATCH IS RELEASED. QUARTERLY DOSE AUDITS ARE CONDUCTED ON A REPRESENTATIVE PRODUCT FROM THE STERILE PACK PREPARED PLATED MEDIA PRODUCT LINE TO ENSURE THAT THE BIOBURDEN REMAINS BELOW THE PRE-DETERMINED LEVEL WHICH ESTABLISHED THE DOSE RANGE FOR THE SAL CLAIM OF 10^-6. THE COMPLAINT HISTORY WAS REVIEWED, AND NO OTHER COMPLAINTS HAVE BEEN TAKEN ON BATCH 0274702. RETENTION SAMPLES FROM BATCH 0274702 WERE AVAILABLE FOR INSPECTION. FIFTY PLATES FROM FIVE UNOPENED SLEEVES WERE INSPECTED AND 0/50 PLATES HAD MICROBIAL GROWTH (TIME STAMPS 1303-1306, 1314). FOR FURTHER INVESTIGATION, INSPECTED RETENTION PLATES WERE INCUBATED AT 20 TO 25 DEGREES C (20 PLATES) AND 33 TO 37 DEGREES C (30 PLATES). NO MICROBIAL GROWTH WAS OBSERVED AT THREE DAYS INCUBATION IN 50/50 RETENTION PLATES. RETURNS WERE RECEIVED FOR INVESTIGATION. TEN PLATES FROM BATCH 0274702 WERE RECEIVED AS ONE OPENED SLEEVE IN A ZIPLOCK BAG SHIPPED IN A BOX WITH BUBBLE WRAP AND PLASTIC BAG PADDING (TIME STAMPS 1431 AND 1432). SURFACE BACTERIAL GROWTH WAS OBSERVED IN 3/10 RETURNED PLATES. THE GROWTH WAS NOT IDENTIFIED FOR THE PLATES DUE BECAUSE PLATES HAD BEEN HANDLED AND RETURN SHIPPED AS LOOSE PLATES. ONE PHOTO ALSO WAS RECEIVED FOR INVESTIGATION. THE PHOTO SHOWS THE AGAR SURFACE A PLATE FROM BATCH 0274402 (TIME STAMP 1432) WITH SURFACE BACTERIAL COLONIES WITH SEVERAL DIFFERENT MORPHOLOGIES. REVIEW OF THE MANUFACTURING PROCESS AND IRRADIATION RECORDS WERE SATISFACTORY FOR BATCH 0274702 AND INSPECTION OF THE RETENTION SAMPLES YIELDED NO SIGNS OF CONTAMINATION. CONTAMINATION CANNOT BE CONFIRMED ON STERILE PRODUCTS THAT HAVE MICROBIAL GROWTH AFTER REMOVAL FROM SEALED SLEEVES. OBSERVATION OF MICROBIAL GROWTH ON PLATES NOT WITHIN SEALED SLEEVES CANNOT CONFIRM A COMPLAINT FOR CONTAMINATION OF STERILE PRODUCTS. THIS COMPLAINT CANNOT BE CONFIRMED. BD WILL CONTINUE TO TREND COMPLAINTS FOR CONTAMINATION.

Description of Event or Problem

IT WAS REPORTED THAT PRIOR TO USE WITH BD RODAC¿ SNAP LID TRYPTICASE¿ SOY AGAR (TSA) WITH LECITHIN & POLYSORBATE THERE WAS VISIBLE GROWTH ON PLATE.

Additional Manufacturer Narrative

A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

Description of Event or Problem

IT WAS REPORTED THAT PRIOR TO USE WITH BD RODAC¿ SNAP LID TRYPTICASE¿ SOY AGAR (TSA) WITH LECITHIN & POLYSORBATE THERE WAS VISIBLE GROWTH ON PLATE.