BD BBL¿ CHOCOLATE II AGAR
Report
- Report Number
- 1119779-2024-00747
- Event Type
- Malfunction
- Date Received
- October 10, 2024
- Date of Event
- September 20, 2024
- Report Date
- August 14, 2025
- Manufacturer
- BECTON DICKINSON & CO. (SPARKS)
- Product Code
- JTY
- UDI-DI
- 10382902212673
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
INVESTIGATION SUMMARY DURING MANUFACTURING OF MATERIAL 221267, 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 REVIEW FOR BATCH 4156528 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, THERE ARE NO OTHER COMPLAINTS TAKEN ON THIS BATCH 4156528 FOR THIS DEFECT. THERE WERE NO RETENTION SAMPLES AVAILABLE FOR INVESTIGATION OF THIS COMPLAINT. THERE ARE 5 PHOTOS AVAILABLE FOR THIS COMPLAINT. 3 PHOTOS SHOW CHOCOLATE PLATES WITH FUNGAL CONTAMINATION, NO BATCH VERIFICATION CAN BE SEEN IN PHOTOS. 1 PHOTO SHOWS A SLEEVE OF CHOCOLATE WITH SLEEVE LABEL (221267/4156528 2024-10-07). THE LAST PHOTO SHOWS 3 SLEEVES OF CHOCOLATE WITH SLEEVE LABELS. NO RETURN SAMPLES AVAILABLE FOR THIS INVESTIGATION. THIS COMPLAINT CAN BE CONFIRMED. NO COMPLAINT TRENDS FOR THIS DEFECT HAVE BEEN IDENTIFIED; NO ACTIONS ARE INDICATED AT THIS TIME. BD WILL CONTINUE TO TREND COMPLAINTS FOR CONTAMINATION.
A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
THE FOLLOWING FIELDS HAVE BEEN UPDATED: B5. IT WAS REPORTED WHILE USING BD BBL¿ CHOCOLATE II AGAR, PATIENT SAMPLE WAS CONTAMINATED WITH MOLD. THERE WAS NO REPORT OF PATIENT IMPACT. THIS SUPPLEMENTAL MDR IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW OF RECORDS DATING APRIL 2023¿2025, UNDER CAPA 11910483.
IT WAS REPORTED THAT BD BBL¿ CHOCOLATE II AGAR HAD AN UNSPECIFIED NUMBER OF PLATES WITH FUNGAL CONTAMINATION OBSERVED BEFORE AND DURING USE. APPROXIMATELY THREE (3) SAMPLES WERE REPORTED AS MOLD WITH A COMMENT OF "PROBABLE CONTAMINANT". THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
IT WAS REPORTED THAT BD BBL¿ CHOCOLATE II AGAR HAD AN UNSPECIFIED NUMBER OF PLATES WITH FUNGAL CONTAMINATION OBSERVED BEFORE AND DURING USE. APPROXIMATELY THREE (3) SAMPLES WERE REPORTED AS MOLD WITH A COMMENT OF "PROBABLE CONTAMINANT". THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
IT WAS REPORTED WHILE USING BD BBL¿ CHOCOLATE II AGAR, A PATIENT SAMPLE WAS CONTAMINATED WITH MOLD. THERE WAS NO REPORT OF PATIENT IMPACT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1924672 | BD BBL¿ CHOCOLATE II AGAR | CULTURE MEDIA, FOR ISOLATION OF PATHOGENIC NEISSERIA | JTY | BECTON DICKINSON & CO. (SPARKS) | 4156528 | 10382902212673 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |