BD BBL¿ TRYPTICASE¿ SOY AGAR (SOYBEAN-CASEIN DIGEST AGAR)
Report
- Report Number
- 1119779-2022-01484
- Event Type
- Malfunction
- Date Received
- December 13, 2022
- Date of Event
- December 5, 2022
- Report Date
- March 6, 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
- NJ, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
H.6 INVESTIGATION SUMMARY: 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 REVIEW FOR BATCH 2277109 WAS 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 NO OTHER COMPLAINTS HAVE BEEN TAKEN ON BATCH 2277109 FOR CONTAMINATION. NO RETENTION SAMPLES FOR THIS BATCH WERE AVAILABLE FOR INVESTIGATION. NO PHOTOS OR 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. ADDITIONAL TRAININGS ARE PLANNED WITH AN ONGOING TRAINING REVIEW FOR CLEANING PROCESSES. IMPROVEMENT IN OBSERVATION OF CONTAMINATION IS EXPECTED AS THE CAPA PROGRESSES. THIS COMPLAINT HAS BEEN CONFIRMED BASED ON THE TREND.
THE FOLLOWING CORRECTIONS WERE MADE. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT BD BBL¿ TRYPTICASE¿ SOY AGAR (SOYBEAN-CASEIN DIGEST AGAR) PLATES WERE SHOWED BACTERIAL GROWTH. NO INJURIES REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER STATES PRODUCT FAILED STERILITY TESTING. VISUAL INSPECTION SHOWED SURFACE BACTERIAL GROWTH.
DEVICE EVALUATED BY MFR: 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) PLATES WERE SHOWED BACTERIAL GROWTH. NO INJURIES REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER STATES PRODUCT FAILED STERILITY TESTING. VISUAL INSPECTION SHOWED SURFACE BACTERIAL GROWTH.
IT WAS REPORTED THAT BD BBL¿ TRYPTICASE¿ SOY AGAR (SOYBEAN-CASEIN DIGEST AGAR) PLATES WERE SHOWED BACTERIAL GROWTH. NO INJURIES REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER STATES PRODUCT FAILED STERILITY TESTING. VISUAL INSPECTION SHOWED SURFACE BACTERIAL GROWTH.
IT WAS REPORTED THAT BD BBL¿ TRYPTICASE¿ SOY AGAR (SOYBEAN-CASEIN DIGEST AGAR) FAILED STERILITY TEST. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER STATES PRODUCT FAILED STERILITY TESTING. HAZARD, INJURY OR ERRONEOUS RESULTS? NO; HAZARD, INJURY OR ERRONEOUS RESULTS DETAILS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1258159 | BD BBL¿ TRYPTICASE¿ SOY AGAR (SOYBEAN-CASEIN DIGEST AGAR) | CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL | JSG | BECTON, DICKINSON & CO. (SPARKS) | 221283 | 2277109 | 10382902212833 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |