BD BBL¿ TRYPTICASE SOY AGAR WITH 5% SHEEP BLOOD (TSA II)
Report
- Report Number
- 1119779-2023-00541
- Event Type
- Malfunction
- Date Received
- May 10, 2023
- Date of Event
- April 24, 2023
- Report Date
- September 1, 2023
- Manufacturer
- BECTON, DICKINSON & CO. (SPARKS)
- Product Code
- JSG
- PMA / PMN Number
- PREAMENDMENT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH ADDITIONAL INFORMATION: D.10 DEVICE AVAILABLE FOR EVAL? YES. D.10 RETURNED TO MANUFACTURER ON: 29-AUG-2023. H.6. INVESTIGATION SUMMARY: THIS MEMO IS TO SUMMARIZE FINDINGS REGARDING THE COMPLAINT RELATED TO CATALOG NUMBER 221261, PLATE TRYPTICASE SOY AGAR 5% SB (B)(4) EA, BATCH NUMBER 3051079 AND BD COMPLAINT NUMBER (B)(4) 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 3051079 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 NO OTHER COMPLAINTS HAVE BEEN TAKEN ON BATCH 3051079. RETENTION SAMPLES FROM BATCH 3051079 WERE NOT AVAILABLE FOR INSPECTION. TEN PLATES FROM BATCH 3051079 WERE RETURNED AS ONE UNOPENED SLEEVE IN A FOAM HOLDER IN AN INSULATED BOX WITH ICE PACKS AND PADDING. PRIOR TO INSPECTION, THE SLEEVE WAS INCUBATED AT 33 TO 37 DEGREES C. AT THREE DAYS INCUBATION, PLATES WERE INSPECTED AND 0/10 RETURNED PLATES HAD MICROBIAL GROWTH (TIME STAMP 0921). FOUR PHOTOS ALSO WERE RECEIVED FOR INVESTIGATION. TWO PHOTOS EACH FEATURE A PLATE PRINT FROM BATCH 3051079 (TIME STAMPS 0918 AND 0925) FOR BATCH VERIFICATION. ANOTHER PHOTO SHOWS THE AGAR SURFACE OF AN OPENED PLATE WITH A COLONY GROWING. THE LAST PHOTO SHOWS THE AGAR SURFACE OF AN OPENED PLATE WITH A COLONY GROWING BUT THERE ALSO APPEARS TO BE STREAK LINES ON THE PLATE. THIS COMPLAINT CAN BE CONFIRMED FOR CONTAMINATION. BD HAS IDENTIFIED A CONTAMINATION TREND FOR THIS PRODUCT AND THE INVESTIGATION FOUND OPPORTUNITIES FOR BIOBURDEN REDUCTION IN THE MANUFACTURING PROCESS. A CAPA (CORRECTIVE AND PREVENTATIVE ACTIONS) HAS BEEN INITIATED AND INVOLVES IMPLEMENTING ADDITIONAL CLEANING EVENTS AND EVALUATION OF MANUFACTURING PROCEDURES FOCUSED ON IN-PROCESS BIOBURDEN REDUCTION. ADDITIONAL TRAININGS ARE PART OF THE IMPLEMENTATION WITH AN ONGOING TRAINING REVIEW FOR CLEANING PROCESSES. IMPROVEMENT IN OBSERVATION OF CONTAMINATION IS EXPECTED AS THE CAPA PROGRESSES. BD WILL CONTINUE TO TREND COMPLAINTS FOR CONTAMINATION.
H.3. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
IT WAS REPORTED THAT WHILE USING BD BBL¿ TRYPTICASE SOY AGAR WITH 5% SHEEP BLOOD (TSA II) THAT THERE WAS CONTAMINATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DISCOVERED VIA VISUAL INSPECTION. BACTERIA OR FUNGI CONTAMINATION ¿ COLONY COLOR?- MOST LIKELY BACTERIAL GIVEN MORPHOLOGY. 1 PLATE HAD AN OFF-WHITE BACTERIAL MASS AND THE OTHER HAD A SMALLER, TRANSPARENT COLONY. LOCATION OF CONTAMINATION ¿ SURFACE OR SUB-SURFACE.- BOTH PLATES HAD GROWTH ON THE SURFACE OF THE AGAR. ONE PLATE HAD THE COLONY TOWARD THE CENTER AND THE OTHER WAS TOWARD THE EDGE OF THE PLATE. WAS ORGANISM GRAM STAINED OR IDENTIFIED?- APPROXIMATE QUANTITY OF PRODUCT RECEIVED IN SHIPMENT AND QUANTITY AFFECTED PLATES? THESE WERE FROM A CASE OF 100 TOTAL PLATES. WE HAVE ONLY OBSERVED TWO PLATE THUS FAR FROM THE SAME SLEEVE WITH CONTAMINATION. CONTAMINATED PLATES WERE DISCOVERED ON THE 24TH OF APRIL. CUSTOMER REPORTS MEDIA 221261_3051079 CONTAMINATED.
IT WAS REPORTED THAT WHILE USING BD BBL¿ TRYPTICASE SOY AGAR WITH 5% SHEEP BLOOD (TSA II) THAT THERE WAS CONTAMINATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DISCOVERED VIA VISUAL INSPECTION. BACTERIA OR FUNGI CONTAMINATION ¿ COLONY COLOR? MOST LIKELY BACTERIAL GIVEN MORPHOLOGY. 1 PLATE HAD AN OFF-WHITE BACTERIAL MASS AND THE OTHER HAD A SMALLER, TRANSPARENT COLONY. LOCATION OF CONTAMINATION ¿ SURFACE OR SUB-SURFACE. BOTH PLATES HAD GROWTH ON THE SURFACE OF THE AGAR. ONE PLATE HAD THE COLONY TOWARD THE CENTER AND THE OTHER WAS TOWARD THE EDGE OF THE PLATE. WAS ORGANISM GRAM STAINED OR IDENTIFIED. APPROXIMATE QUANTITY OF PRODUCT RECEIVED IN SHIPMENT AND QUANTITY AFFECTED PLATES? THESE WERE FROM A CASE OF 100 TOTAL PLATES. WE HAVE ONLY OBSERVED TWO PLATE THUS FAR FROM THE SAME SLEEVE WITH CONTAMINATION. CONTAMINATED PLATES WERE DISCOVERED ON THE 24TH OF APRIL. CUSTOMER REPORTS MEDIA 221261_3051079 CONTAMINATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 688178 | BD BBL¿ TRYPTICASE SOY AGAR WITH 5% SHEEP BLOOD (TSA II) | CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL | JSG | BECTON, DICKINSON & CO. (SPARKS) | 3051079 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |