BD BBL¿ TRYPTICASE SOY AGAR WITH 5% SHEEP BLOOD (TSA II)
Report
- Report Number
- 1119779-2023-00116
- Event Type
- Malfunction
- Date Received
- February 9, 2023
- Date of Event
- January 31, 2023
- Report Date
- March 20, 2023
- Manufacturer
- BECTON, DICKINSON & CO. (SPARKS)
- Product Code
- JSG
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- PHARMACIST
- Health Professional
- Yes
Narratives
H.6 INVESTIGATION SUMMARY: THIS MEMO IS TO SUMMARIZE FINDINGS REGARDING THE COMPLAINT RELATED TO CATALOG NUMBER 221261, PLATE TRYPTICASE SOY AGAR 5% SB 100 EA, BATCH NUMBER 2258131 AND BD COMPLAINT NUMBER 7111848 FOR CONTAMINATION. DURING MANUFACTURING OF MATERIAL 221261, 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 2258131WAS SATISFACTORY PER INTERNAL PROCEDURES. 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 THE ONLY TWO COMPLAINTS ON BATCH 2258131 ARE FROM ATCC. RETENTION SAMPLES FROM BATCH 2258131 ARE NOT AVAILABLE FOR INSPECTION. FOUR PHOTOS WERE RECEIVED FOR INVESTIGATION. THREE PHOTOS EACH SHOW A CLOSE UP OF THE SIDE OF A SLEEVE OF MEDIUM RED AGAR PLATES WITH MICROBIAL GROWTH VISIBLE IN AT LEAST ONE PLATE. THE LAST PHOTO SHOWS THE SIDE OF THREE SLEEVES OF MEDIUM RED AGAR PLATES WITH AT LEAST ONE PLATE IN EACH SLEEVE WITH MICROBIAL GROWTH VISIBLE. NO PRODUCT LABELS WERE READABLE FOR BATCH VERIFICATION IN THE PHOTOS. NO RETURN SAMPLES WERE RECEIVED FOR INVESTIGATION OF THIS COMPLAINT. BD HAS IDENTIFIED A CONTAMINATION TREND FOR THIS PRODUCT AND THE INVESTIGATION FOUND OPPORTUNITIES FOR BIOBURDEN REDUCTION IN THE MANUFACTURING PROCESS. THIS COMPLAINT CAN BE CONFIRMED. BD WILL CONTINUE TO TREND COMPLAINTS FOR CONTAMINATION. SEE H.10
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¿ TRYPTICASE SOY AGAR WITH 5% SHEEP BLOOD (TSA II) 3 PLATES IN UNOPENED SLEEVES WERE FOUND TO BE CONTAMINATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THREE PLATES IN UNOPENED SLEEVES WERE FOUND TO BE CONTAMINATED (THREE SEPARATE SLEEVES, ONE CONTAMINATED PLATE IN EACH SLEEVE).
IT WAS REPORTED THAT BD BBL¿ TRYPTICASE SOY AGAR WITH 5% SHEEP BLOOD (TSA II) 3 PLATES IN UNOPENED SLEEVES WERE FOUND TO BE CONTAMINATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THREE PLATES IN UNOPENED SLEEVES WERE FOUND TO BE CONTAMINATED (THREE SEPARATE SLEEVES, ONE CONTAMINATED PLATE IN EACH SLEEVE).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1318742 | BD BBL¿ TRYPTICASE SOY AGAR WITH 5% SHEEP BLOOD (TSA II) | CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL | JSG | BECTON, DICKINSON & CO. (SPARKS) | 2258131 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |