BD BBL¿ COOKED MEAT MEDIUM

Report

Report Number: 1119779-2021-01793
Event Type: Malfunction
Date Received: November 9, 2021
Date of Event: October 13, 2021
Report Date: April 15, 2022
Manufacturer: BECTON, DICKINSON & CO. (SPARKS)
Product Code: KZI
UDI-DI: 30382902215081
PMA / PMN Number: PREAMEND
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: BE
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

H.6. INVESTIGATION: MATERIAL 221508 IS MANUFACTURED BY REHYDRATING THE MEDIA COMPONENTS WITH USP PURIFIED WATER, AND THOROUGHLY MIXING UNTIL A HOMOGENEOUS SOLUTION IS OBTAINED. MEAT PELLETS ARE DISPENSED INTO EMPTY TUBES PER PROCEDURES. THE TUBES ARE FILLED WITH PROCESSED WATER, CAPPED, TORQUED AND THEN LABELED BY MACHINE PER STANDARD OPERATING PROCEDURE (SOP). THE TUBES ARE TERMINALLY AUTOCLAVED IN AN AIR OVER PRESSURE (AOP) AUTOCLAVE, PER MANUFACTURING INSTRUCTIONS, USING A VALIDATED CYCLE. POST AUTOCLAVING, TUBES ARE PACKAGED INTO FINAL SHIPPING CONFIGURATIONS. BATCH 0239335: THE BATCH HISTORY RECORD REVIEW FOR BATCH 0239335 WAS SATISFACTORY AND NO NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND INSPECTION. IN PROCESS CHECKS WERE PERFORMED AT THE DESIGNATED INTERVALS. THOSE CHECKS CONFIRMED THAT THE CAPS WERE TIGHTENED TO THE VALIDATED SPECIFICATIONS PER INTERNAL PROCEDURE AND FILL VOLUMES WERE WITHIN SPECIFICATIONS. QC INSPECTION AND TESTING WERE SATISFACTORY AT TIME OF RELEASE. ALSO, EACH BATCH HISTORY RECORD IS REVIEWED TO CONFIRM THE FOLLOWING PRIOR TO RELEASE: --THE TOTAL ELAPSED TIME BETWEEN END OF FORMULATION AND START OF THE AUTOCLAVE CYCLE WAS WITHIN THE SPECIFIED LIMITS. --ALL AUTOCLAVE PARAMETERS CONFORMED TO THE VALIDATED CYCLE PARAMETERS FOR THIS PRODUCT. --THE MINIMUM F0 FOR THIS PRODUCT WAS MET. THE COMPLAINT HISTORY WAS REVIEWED, AND NO OTHER COMPLAINT HAS BEEN TAKEN ON THIS BATCH. RETENTION SAMPLES FROM BATCH 0239335 (10 TUBES) WERE AVAILABLE FOR INSPECTION. NO MEDIA DEFECTS WERE OBSERVED IN 10/10 RETENTION TUBES. NO EVIDENCE OF CONTAMINATION WAS OBSERVED IN THE RETENTION SAMPLES. FOR FURTHER INVESTIGATION TWO RETENTION TUBES WERE INCUBATED. ONE RETENTION TUBE WAS PLACED IN THE 33¿37-DEGREE CELSIUS INCUBATOR AND ONE RETENTION TUBE WAS PLACED IN THE 20¿25-DEGREE CELSIUS INCUBATOR. AT THE END OF A SEVEN-DAY INCUBATION PERIOD NO MICROBIAL GROWTH WAS OBSERVED AT EITHER TEMPERATURE. BATCH 0274258: THE BATCH HISTORY RECORD REVIEW FOR BATCH 0274258 WAS SATISFACTORY AND NO NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND INSPECTION. IN PROCESS CHECKS WERE PERFORMED AT THE DESIGNATED INTERVALS. THOSE CHECKS CONFIRMED THAT THE CAPS WERE TIGHTENED TO THE VALIDATED SPECIFICATIONS PER INTERNAL PROCEDURE AND FILL VOLUMES WERE WITHIN SPECIFICATIONS. QC INSPECTION AND TESTING WERE SATISFACTORY AT TIME OF RELEASE. ALSO, EACH BATCH HISTORY RECORD IS REVIEWED TO CONFIRM THE FOLLOWING PRIOR TO RELEASE: --THE TOTAL ELAPSED TIME BETWEEN END OF FORMULATION AND START OF THE AUTOCLAVE CYCLE WAS WITHIN THE SPECIFIED LIMITS. --ALL AUTOCLAVE PARAMETERS CONFORMED TO THE VALIDATED CYCLE PARAMETERS FOR THIS PRODUCT. --THE MINIMUM F0 FOR THIS PRODUCT WAS MET. THE COMPLAINT HISTORY WAS REVIEWED, AND NO OTHER COMPLAINT HAS BEEN TAKEN ON THIS BATCH. RETENTION SAMPLES FROM BATCH 0274258 (10 TUBES) WERE AVAILABLE FOR INSPECTION. NO MEDIA DEFECTS WERE OBSERVED IN 10/10 RETENTION TUBES. NO EVIDENCE OF CONTAMINATION WAS OBSERVED IN THE RETENTION SAMPLES. FOR FURTHER INVESTIGATION TWO RETENTION TUBES WERE INCUBATED. ONE RETENTION TUBE WAS PLACED IN THE 33¿37-DEGREE CELSIUS INCUBATOR AND ONE RETENTION TUBE WAS PLACED IN THE 20¿25-DEGREE CELSIUS INCUBATOR. AT THE END OF A SEVEN-DAY INCUBATION PERIOD NO MICROBIAL GROWTH WAS OBSERVED AT EITHER TEMPERATURE. BATCH 1035036: THE BATCH HISTORY RECORD REVIEW FOR BATCH 1035036 WAS SATISFACTORY AND NO NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND INSPECTION. IN PROCESS CHECKS WERE PERFORMED AT THE DESIGNATED INTERVALS. THOSE CHECKS CONFIRMED THAT THE CAPS WERE TIGHTENED TO THE VALIDATED SPECIFICATIONS PER INTERNAL PROCEDURE AND FILL VOLUMES WERE WITHIN SPECIFICATIONS. QC INSPECTION AND TESTING WERE SATISFACTORY AT TIME OF RELEASE. ALSO, EACH BATCH HISTORY RECORD IS REVIEWED TO CONFIRM THE FOLLOWING PRIOR TO RELEASE: --THE TOTAL ELAPSED TIME BETWEEN END OF FORMULATION AND START OF THE AUTOCLAVE CYCLE WAS WITHIN THE SPECIFIED LIMITS. --ALL AUTOCLAVE PARAMETERS CONFORMED TO THE VALIDATED CYCLE PARAMETERS FOR THIS PRODUCT. --THE MINIMUM F0 FOR THIS PRODUCT WAS MET. THE COMPLAINT HISTORY WAS REVIEWED, AND NO OTHER COMPLAINT HAS BEEN TAKEN ON THIS BATCH. RETENTION SAMPLES FROM BATCH 1035036 (10 TUBES) WERE AVAILABLE FOR INSPECTION. NO MEDIA DEFECTS WERE OBSERVED IN 10/10 RETENTION TUBES. NO EVIDENCE OF CONTAMINATION WAS OBSERVED IN THE RETENTION SAMPLES. FOR FURTHER INVESTIGATION TWO RETENTION TUBES WERE INCUBATED. ONE RETENTION TUBE WAS PLACED IN THE 33¿37-DEGREE CELSIUS INCUBATOR AND ONE RETENTION TUBE WAS PLACED IN THE 20¿25-DEGREE CELSIUS INCUBATOR. AT THE END OF A SEVEN-DAY INCUBATION PERIOD NO MICROBIAL GROWTH WAS OBSERVED AT EITHER TEMPERATURE. BATCH 1140891: THE BATCH HISTORY RECORD REVIEW FOR BATCH 1140891 WAS SATISFACTORY AND NO NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND INSPECTION. IN PROCESS CHECKS WERE PERFORMED AT THE DESIGNATED INTERVALS. THOSE CHECKS CONFIRMED THAT THE CAPS WERE TIGHTENED TO THE VALIDATED SPECIFICATIONS PER INTERNAL PROCEDURE AND FILL VOLUMES WERE WITHIN SPECIFICATIONS. QC INSPECTION AND TESTING WERE SATISFACTORY AT TIME OF RELEASE. ALSO, EACH BATCH HISTORY RECORD IS REVIEWED TO CONFIRM THE FOLLOWING PRIOR TO RELEASE: --THE TOTAL ELAPSED TIME BETWEEN END OF FORMULATION AND START OF THE AUTOCLAVE CYCLE WAS WITHIN THE SPECIFIED LIMITS. --ALL AUTOCLAVE PARAMETERS CONFORMED TO THE VALIDATED CYCLE PARAMETERS FOR THIS PRODUCT. --THE MINIMUM F0 FOR THIS PRODUCT WAS MET. THE COMPLAINT HISTORY WAS REVIEWED, AND NO OTHER COMPLAINT HAS BEEN TAKEN ON THIS BATCH. RETENTION SAMPLES FROM BATCH 1140891 (10 TUBES) WERE AVAILABLE FOR INSPECTION. NO MEDIA DEFECTS WERE OBSERVED IN 10/10 RETENTION TUBES. NO EVIDENCE OF CONTAMINATION WAS OBSERVED IN THE RETENTION SAMPLES. FOR FURTHER INVESTIGATION TWO RETENTION TUBES WERE INCUBATED. ONE RETENTION TUBE WAS PLACED IN THE 33¿37-DEGREE CELSIUS INCUBATOR AND ONE RETENTION TUBE WAS PLACED IN THE 20¿25-DEGREE CELSIUS INCUBATOR. AT THE END OF A SEVEN-DAY INCUBATION PERIOD NO MICROBIAL GROWTH WAS OBSERVED AT EITHER TEMPERATURE. NO PHOTOS WERE RECEIVED TO ASSIST WITH THE INVESTIGATION. NO RETURNS WERE RECEIVED TO ASSIST WITH THE INVESTIGATION. THIS COMPLAINT CANNOT BE CONFIRMED FOR ANY BATCH. BD WILL CONTINUE TO TREND COMPLAINTS FOR CONTAMINATION FOR EACH BATCH. IT IS NOTED THAT MATERIAL 221508 COOKED MEAT MEDIUM IS NOT AN APPROPRIATE MEDIUM FROM WHICH TO PERFORM DIRECT TESTING USING MOLECULAR METHODS. COOKED MEAT MEDIUM CONTAINS COMPONENTS OF ANIMAL ORIGIN. THE CERTIFICATE OF ANALYSIS FOR EACH BATCH OF THIS PRODUCT INCLUDES THE ANIMAL ORIGIN DATA. DUE TO THIS, THE MEDIUM MAY CONTAIN ANIMAL GENETIC MATERIAL AND DEAD MICROORGANISMS WHICH CAN INTERFERE WITH MOLECULAR TESTING METHODS SUCH AS PCR.

Additional Manufacturer Narrative · 0

(B)(6). THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1140891, MEDICAL DEVICE EXPIRATION DATE: 2022-11-13, DEVICE MANUFACTURE DATE: 2021-05-20. MEDICAL DEVICE LOT #: 0274258, MEDICAL DEVICE EXPIRATION DATE: 2022-04-02, DEVICE MANUFACTURE DATE: 2020-09-30. MEDICAL DEVICE LOT #: 0239335, MEDICAL DEVICE EXPIRATION DATE: 2022-02-26, DEVICE MANUFACTURE DATE: 2020-08-26. MEDICAL DEVICE LOT #: 1035036, MEDICAL DEVICE EXPIRATION DATE: 2022-08-07, DEVICE MANUFACTURE DATE: 2021-02-04. 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 · 0

IT WAS REPORTED THAT WHILE TESTING ON BD BBL¿ COOKED MEAT MEDIUM OBTAINED A FALSE POSITIVE RESULT . THERE WAS NO INDICATION THAT RESULTS WERE REPORTED, AND THERE WAS NO PATIENT IMPACT. CONFIRMATORY PCR TESTING WAS PERFORMED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER IS USING THE INOCULATED COOKED MEAT MEDIUM TO ENHANCE THE GROWTH OF CLOSTRIDIUM PERFRINGENS AND CLOSTRIDIUM BOTULINUM. AFTERWARDS THEY SUBCULTURE THE COOKED MEAT MEDIUM ONTO TRYPTOSE GLUCOSE YEAST AGAR. TO CONFIRM THE PRESENCE OF CLOSTRIDIUM PERFRINGENS , THEY PERFORM A PCR TEST TO DETECT CPA GEN = ALPHA TOXIN GEN OF CLOSTRIDIUM PERFRINGENS. FOR QUALITY PURPOSE THEY ALSO PERFORM A PCR TEST FROM AN UNINOCULATED COOKED MEAT MEDIUM TUBE (WITHOUT SAMPLE) AND FOUND OUT THAT THE MEDIUM ITSELF CONTAIN A HIGH DOSE OF ALPHA TOXIN GEN OF CLOSTRIDIUM PERFRINGENS, RESULTING IN FALSE POSITIVE PCR RESULTS. THEREFORE CUSTOMER CONSIDER THE COOKED MEAT MEDIUM TUBES CONTAMINATED.

Description of Event or Problem · 0

IT WAS REPORTED THAT WHILE TESTING ON BD BBL¿ COOKED MEAT MEDIUM OBTAINED A FALSE POSITIVE RESULT . THERE WAS NO INDICATION THAT RESULTS WERE REPORTED, AND THERE WAS NO PATIENT IMPACT. CONFIRMATORY PCR TESTING WAS PERFORMED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER IS USING THE INOCULATED COOKED MEAT MEDIUM TO ENHANCE THE GROWTH OF CLOSTRIDIUM PERFRINGENS AND CLOSTRIDIUM BOTULINUM. AFTERWARDS THEY SUBCULTURE THE COOKED MEAT MEDIUM ONTO TRYPTOSE GLUCOSE YEAST AGAR. TO CONFIRM THE PRESENCE OF CLOSTRIDIUM PERFRINGENS , THEY PERFORM A PCR TEST TO DETECT CPA GEN = ALPHA TOXIN GEN OF CLOSTRIDIUM PERFRINGENS. FOR QUALITY PURPOSE THEY ALSO PERFORM A PCR TEST FROM AN UNINOCULATED COOKED MEAT MEDIUM TUBE (WITHOUT SAMPLE) AND FOUND OUT THAT THE MEDIUM ITSELF CONTAIN A HIGH DOSE OF ALPHA TOXIN GEN OF CLOSTRIDIUM PERFRINGENS, RESULTING IN FALSE POSITIVE PCR RESULTS. THEREFORE CUSTOMER CONSIDER THE COOKED MEAT MEDIUM TUBES CONTAMINATED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1677198	BD BBL¿ COOKED MEAT MEDIUM	CULTURE MEDIA, ENRICHED	KZI	BECTON, DICKINSON & CO. (SPARKS)	221508	SEE H10	30382902215081

Patients

Seq	Age	Sex	Outcome	Treatment
1		Unknown