BD BBL¿ SABOURAUD DEXTROSE AGAR (DEEP FILL)
Report
- Report Number
- 1119779-2023-00488
- Event Type
- Malfunction
- Date Received
- April 26, 2023
- Date of Event
- April 4, 2023
- Report Date
- June 19, 2023
- Manufacturer
- BECTON, DICKINSON & CO. (SPARKS)
- Product Code
- JSI
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
H6. INVESTIGATION SUMMARY: THIS MEMO IS TO SUMMARIZE FINDINGS REGARDING THE COMPLAINT RELATED TO CATALOG NUMBER 221278, PLATE SABOURAUD DEXTROSE AGAR 100 EA, BATCH NUMBERS 2305727 AND 3004744 AND BD COMPLAINT NUMBER 7641540 FOR CONTAMINATION. DURING MANUFACTURING OF MATERIAL 221278, 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 RECORDS FOR BATCH 2305727 AND BATCH 3004744 WERE SATISFACTORY AND NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND INSPECTION OF EITHER BATCH. 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 THESE BATCHES 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 OTHER COMPLAINTS HAVE BEEN TAKEN ON BATCH 2305727 FOR CONTAMINATION. NO OTHER COMPLAINTS HAVE BEEN TAKEN ON BATCH 3004744. RETENTION SAMPLES FROM BATCH 2305727 AND BATCH 3004744 WERE NOT AVAILABLE FOR INSPECTION. TWELVE PHOTOS WERE RECEIVED FOR INVESTIGATION. TWO PHOTOS EACH SHOW THE SIDE OF TWO SLEEVES FROM BATCH 2305727 WITH MICROBIAL VISIBLE IN AT LEAST ONE PLATE OF EACH SLEEVE. ONE PHOTO SHOWS THE BOTTOM OF AN OPENED SLEEVE FROM BATCH 2305727 (TIME STAMP 0110) WITH MICROBIAL GROWTH VISIBLE IN THE BOTTOM PLATE. THREE PHOTOS EACH SHOW TWO PLATES FROM BATCH 2305727 (TIME STAMP 0110) WITH MICROBIAL GROWTH IN EACH PLATE. ONE PHOTO SHOWS THE BOTTOM OF A PLATE FROM BATCH 2305727 (TIME STAMP 0110) WITH MICROBIAL GROWTH. ONE PHOTO SHOWS THE BOTTOM OF A PLATE FROM BATCH 3004744 (TIME STAMP 0350) WITH MICROBIAL GROWTH. ONE PHOTO SHOWS THE BOTTOM OF TWO SLEEVES WITH MICROBIAL GROWTH VISIBLE IN THE BOTTOM PLATES. ONE PHOTO SHOWS THE SIDE OF THREE SLEEVES WITH MICROBIAL GROWTH VISIBLE IN AT LEAST ONE PLATE OF EACH SLEEVE. TWO PHOTOS EACH SHOW A CLOSE UP OF THE SIDE OF A SLEEVE. COMMENTS WERE NOTED ABOUT SLEEVE SEAL ("SEAM") AND THAT THE SLEEVE MATERIAL WAS "VERY TIGHT AROUND THE PLATES". NO SLEEVE DEFECTS WERE NOTED IN THE PHOTOS. NO RETURN SAMPLES WERE RECEIVED FOR INVESTIGATION. THIS COMPLAINT CAN BE CONFIRMED FOR CONTAMINATION IN BOTH BATCHES. BD HAS IDENTIFIED A CONTAMINATION TREND FOR THIS PRODUCT AND THE INVESTIGATION FOUND OPPORTUNITIES FOR BIOBURDEN REDUCTION IN THE MANUFACTURING PROCESS. A CAPA (CORRECTIVE AND PREVENTATIVE ACTIONS) HAS BEEN INITIATED AND INVOLVES IMPLEMENTING ADDITIONAL CLEANING EVENTS AND EVALUATION OF MANUFACTURING PROCEDURES FOCUSED ON IN-PROCESS BIOBURDEN REDUCTION. ADDITIONAL TRAININGS ARE PLANNED WITH AN ONGOING TRAINING REVIEW FOR CLEANING PROCESSES. IMPROVEMENT IN OBSERVATION OF CONTAMINATION IS EXPECTED AS THE CAPA PROGRESSES. BD WILL CONTINUE TO TREND COMPLAINTS FOR CONTAMINATION.
THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH ADDITIONAL LOT NUMBER IS AS FOLLOWS: D4. MEDICAL DEVICE LOT#: 2305727. D4. MEDICAL DEVICE EXPIRATION DATE: 07-APR-2023. H4. DEVICE MANUFACTURE DATE: 01-NOV-2022. D4. MEDICAL DEVICE LOT#: 3004744. D4. MEDICAL DEVICE EXPIRATION DATE: 06-JUN-2023. H4. DEVICE MANUFACTURE DATE: 04-JAN-2023. H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.
IT WAS REPORTED THAT BD BBL¿ SABOURAUD DEXTROSE AGAR (DEEP FILL) BACTERIAL CONTAMINATION WAS FOUND ON 17 PLATES WHILE THEY WERE IN THE PACKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTS SEEING BACTERIAL GROWTH ON PLATES WHILE THEY ARE IN THE PACKAGING. THE CONTAMINATION FROM THE FIRST BOX HAS SEVERAL COLORS INCLUDING GREEN, PURPLE AND YELLOW BACTERIAL COLONIES AND ONE MOLD. A SAMPLE FROM ONE OF THE SIX SLEEVES WAS GRAM STAINED, FOR A TOTAL OF 8 COLONIES. 6 WERE GRAM STAINED AS GRAM-NEGATIVE RODS AND 2 WERE GRAM VARIABLE RODS. THERE WERE 17 CONTAMINATED PLATES FROM THIS SHIPMENT.
IT WAS REPORTED THAT BD BBL¿ SABOURAUD DEXTROSE AGAR (DEEP FILL) BACTERIAL CONTAMINATION WAS FOUND ON 17 PLATES WHILE THEY WERE IN THE PACKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTS SEEING BACTERIAL GROWTH ON PLATES WHILE THEY ARE IN THE PACKAGING. THE CONTAMINATION FROM THE FIRST BOX HAS SEVERAL COLORS INCLUDING GREEN, PURPLE AND YELLOW BACTERIAL COLONIES AND ONE MOLD. A SAMPLE FROM ONE OF THE SIX SLEEVES WAS GRAM STAINED, FOR A TOTAL OF 8 COLONIES. 6 WERE GRAM STAINED AS GRAM-NEGATIVE RODS AND 2 WERE GRAM VARIABLE RODS. THERE WERE 17 CONTAMINATED PLATES FROM THIS SHIPMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1745786 | BD BBL¿ SABOURAUD DEXTROSE AGAR (DEEP FILL) | CULTURE MEDIA, SELECTIVE AND DIFFERENTIAL | JSI | BECTON, DICKINSON & CO. (SPARKS) | SEE H.10 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |