BD BBL TRYPTICASE SOY AGAR WITH 5% SHEEP BLOOD (TSA II) // MACCONKEY II AGAR
Report
- Report Number
- 1119779-2021-00761
- Event Type
- Malfunction
- Date Received
- May 3, 2021
- Date of Event
- April 9, 2021
- Report Date
- October 7, 2021
- Manufacturer
- BECTON, DICKINSON & CO. (SPARKS)
- Product Code
- JSG
- UDI-DI
- 10382902212918
- PMA / PMN Number
- PREAMENDMENT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.
H.6. INVESTIGATION: DURING MANUFACTURING OF MATERIAL 221291, 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 1007791 WAS SATISFACTORY AT TIME OF RELEASE AND NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND INSPECTION. THE RELEASE TESTING THAT IS PERFORMED ON THIS PRODUCT DOES INCLUDE PHYSICAL ATTRIBUTE AND BIOBURDEN TESTING. A SAMPLE OF PLATES ARE INCUBATED AT 25 DEGREES C AND AT 35 DEGREES C FOR APPROXIMATELY 72 HOURS. ALL PHYSICAL ATTRIBUTE AND 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 WAS TAKEN ON BATCH 1007791 FOR CONTAMINATION. TWO PHOTOS WERE RECEIVED FOR INVESTIGATION. ONE PHOTO SHOWS THE BOTTOM OF A PLATE FROM BATCH 1007791 (TIME STAMP 0606) WITH MACCONKEY AGAR IN ONE HALF OF THE BI-PLATE AND NO MEDIA IN THE OTHER BI-PLATE HALF. THE OTHER PHOTO SHOWS AGAR SURFACE OF SEVEN OPENED BI-PLATES. IN THE PHOTO, THERE APPEARS TO BE MICROBIAL GROWTH IN THE TSA WITH 5% SB AGAR OF THREE PLATES. NO RETURN SAMPLES WERE RECEIVED FOR INVESTIGATION. THIS COMPLAINT CAN BE CONFIRMED FOR CONTAMINATION, IN BATCH 1007791. BD WILL CONTINUE TO TREND COMPLAINTS FOR CONTAMINATION AND AGAR DEFECTS. DUE TO THE LOW DEFECT RATE FOR THIS BATCH, NO ACTIONS ARE PLANNED AT THIS TIME. H3 OTHER TEXT : SEE H.10.
IT WAS REPORTED THAT WHILE USING BD BBL¿ TRYPTICASE¿ SOY AGAR WITH 5% SHEEP BLOOD (TSA II) // MACCONKEY II AGAR CONTAMINATION AND A PHYSICAL DEFECT WERE OBSERVED BY THE LABORATORY PERSONNEL. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " IT WAS REPORTED THAT AGAR HAS BACTERIAL CONTAMINATION, MISSING AGAR, AGAR FALLOUT AND BUBBLES. "
IT WAS REPORTED THAT WHILE USING BD BBL¿ TRYPTICASE¿ SOY AGAR WITH 5% SHEEP BLOOD (TSA II) // MACCONKEY II AGAR CONTAMINATION AND A PHYSICAL DEFECT WERE OBSERVED BY THE LABORATORY PERSONNEL. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " IT WAS REPORTED THAT AGAR HAS BACTERIAL CONTAMINATION, MISSING AGAR, AGAR FALLOUT AND BUBBLES. ".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 658799 | BD BBL TRYPTICASE SOY AGAR WITH 5% SHEEP BLOOD (TSA II) // MACCONKEY II AGAR | CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL | JSG | BECTON, DICKINSON & CO. (SPARKS) | 221291 | 1007791 | 10382902212918 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |