BD BBL¿ TRYPTICASE SOY AGAR WITH 5% SHEEP BLOOD (TSA II)
Report
- Report Number
- 1119779-2022-01088
- Event Type
- Malfunction
- Date Received
- August 10, 2022
- Date of Event
- August 3, 2022
- Report Date
- March 27, 2023
- Manufacturer
- BECTON, DICKINSON & CO. (SPARKS)
- Product Code
- JSG
- PMA / PMN Number
- PREAMENDMENT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
H.6 INVESTIGATION SUMMARY: 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 2131362 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, AND ONE OTHER COMPLAINT HAS BEEN TAKEN ON BATCH 2131362 FOR CONTAMINATION. RETENTION SAMPLES FROM BATCH 2131362 WERE NOT AVAILABLE FOR INSPECTION. TWO PHOTOS WERE RECEIVED FOR INVESTIGATION. BOTH PHOTOS SHOW THE AGAR SURFACE OF ONE OR TWO OPENED PLATES WITH MICROBIAL GROWTH IN EACH PLATE. NO PLATE PRINT OR PRODUCT LABELS ARE VISIBLE IN THE PHOTO FOR BATCH VERIFICATION. NO RETURN SAMPLES WERE RECEIVED FOR INVESTIGATION. WITHOUT BATCH VERIFICATION, THIS COMPLAINT CANNOT BE CONFIRMED BY THE PHOTOS PROVIDED. THIS COMPLAINT CANNOT BE CONFIRMED. BD WILL CONTINUE TO TREND COMPLAINTS FOR CONTAMINATION.
IT WAS REPORTED BY THE CUSTOMER THAT OUT OF A LOT OF 400 PLATES CUSTOMER HAS FOUND CONTAMINATION AND GROWTH IN 60 ODD PLATES BEFORE THE USAGE OF PLATES FOR TESTING .BD BBL¿ TRYPTICASE SOY AGAR WITH 5% SHEEP BLOOD (TSA II). REPEAT TESTING WAS PERFORMED. NO PATIENT IMPACT WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: OUT OF A LOT OF 400 PLATES CUSTOMER HAS FOUND CONTAMINATION AND GROWTH IN 60 ODD PLATES BEFORE THE USAGE OF PLATES FOR TESTING.
IT WAS REPORTED BY THE CUSTOMER THAT OUT OF A LOT OF 400 PLATES CUSTOMER HAS FOUND CONTAMINATION AND GROWTH IN 60 ODD PLATES BEFORE THE USAGE OF PLATES FOR TESTING .BD BBL¿ TRYPTICASE SOY AGAR WITH 5% SHEEP BLOOD (TSA II). REPEAT TESTING WAS PERFORMED. NO PATIENT IMPACT WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: OUT OF A LOT OF 400 PLATES CUSTOMER HAS FOUND CONTAMINATION AND GROWTH IN 60 ODD PLATES BEFORE THE USAGE OF PLATES FOR TESTING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1786611 | BD BBL¿ TRYPTICASE SOY AGAR WITH 5% SHEEP BLOOD (TSA II) | CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL | JSG | BECTON, DICKINSON & CO. (SPARKS) | 2131362 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |