BD BBL¿ TRYPTICASE¿ SOY AGAR (SOYBEAN-CASEIN DIGEST AGAR)
Report
- Report Number
- 1119779-2022-01416
- Event Type
- Malfunction
- Date Received
- November 22, 2022
- Date of Event
- September 16, 2022
- Report Date
- March 31, 2023
- Manufacturer
- BECTON, DICKINSON & CO. (SPARKS)
- Product Code
- JSG
- UDI-DI
- 10382902212833
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
H.6 INVESTIGATION SUMMARY: THIS MEMO IS TO SUMMARIZE FINDINGS REGARDING THE COMPLAINT RELATED TO CATALOG NUMBER 221283, PLATE TRYPTICASE SOY AGAR 100 EA, BATCH NUMBER 2189895 AND BD COMPLAINT NUMBER 6555909 FOR CONTAMINATION. DURING MANUFACTURING OF MATERIAL 221283, 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 2189895 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 OTHER COMPLAINTS HAVE BEEN TAKEN ON BATCH 2189895 FOR CONTAMINATION. RETENTION SAMPLES FROM BATCH 2189895 WERE NOT AVAILABLE FOR INSPECTION. TWO PHOTOS WERE RECEIVED FOR INVESTIGATION. EACH PHOTO SHOWS A PARAFILMED PLATE FROM BATCH 2189895 (TIME STAMP 2013) WITH MICROBIAL GROWTH. NO RETURN SAMPLES WERE RECEIVED FOR INVESTIGATION. THIS COMPLAINT CAN BE CONFIRMED. BD HAS IDENTIFIED A CONTAMINATION TREND FOR THIS PRODUCT AND THE INVESTIGATION FOUND OPPORTUNITIES FOR BIOBURDEN REDUCTION IN THE MANUFACTURING PROCESS. H3 OTHER TEXT : 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 (SOYBEAN-CASEIN DIGEST AGAR) CONTAMINATION OCCURRED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER STATES CATALOG 221283 LOT NO. 2189895 IS CONTAMINATED UPON RECEIPT. HAZARD, INJURY OR ERRONEOUS RESULTS? NO. HAZARD, INJURY OR ERRONEOUS RESULTS DETAILS.
IT WAS REPORTED THAT BD BBL¿ TRYPTICASE¿ SOY AGAR (SOYBEAN-CASEIN DIGEST AGAR) CONTAMINATION OCCURRED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER STATES CATALOG 221283 LOT NO. 2189895 IS CONTAMINATED UPON RECEIPT. HAZARD, INJURY OR ERRONEOUS RESULTS? NO. HAZARD, INJURY OR ERRONEOUS RESULTS DETAILS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2731788 | BD BBL¿ TRYPTICASE¿ SOY AGAR (SOYBEAN-CASEIN DIGEST AGAR) | CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL | JSG | BECTON, DICKINSON & CO. (SPARKS) | 221283 | 2189895 | 10382902212833 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |