BD BBL¿ TRYPTICASE¿ SOY AGAR (SOYBEAN-CASEIN DIGEST AGAR)
Report
- Report Number
- 1119779-2024-00441
- Event Type
- Malfunction
- Date Received
- May 29, 2024
- Date of Event
- May 3, 2024
- Report Date
- December 27, 2024
- Manufacturer
- BECTON DICKINSON & CO. (SPARKS)
- Product Code
- JSG
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PR, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVALUATION: YES. H.3 DEVICE EVAL BY MANUFACTURER? YES. D9: RETURNED TO MANUFACTURER ON: 16-MAY-2024. INVESTIGATION SUMMARY: THIS MEMO IS TO SUMMARIZE FINDINGS REGARDING THE COMPLAINT RELATED TO CATALOG NUMBER: 221283, PLATE TRYPTICASE SOY AGAR 100 EA, BATCH NUMBER: 4032739 AND BD COMPLAINT NUMBER: (B)(4) FOR CONTAMINATION (FAILED STERILITY) AND PH VARIANCE. 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: 4032739 WAS SATISFACTORY AND NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND INSPECTION. REVIEW OF THE MANUFACTURING RECORDS CONFIRMED CORRECT FORMULATION, AND ALL MANUFACTURING PROCESSES WERE WITHIN SPECIFICATIONS. ALL BATCHES ARE TESTED PRIOR TO RELEASE AND RESULTS REPORTED ON THE CERTIFICATE OF ANALYSIS WHICH CAN BE OBTAINED AT WWW.BD.COM/REGDOCS. TRYPTICASE SOY AGAR IS STABILITY TESTED BIENNIALLY FOR BIOLOGICAL PERFORMANCE TO ENSURE SATISFACTORY PERFORMANCE THROUGHOUT SHELF LIFE WITH THE ORGANISMS THAT ARE REPORTED ON THE CERTIFICATE OF ANALYSIS. ALL PERFORMANCE TESTING ON THIS BATCH WAS SATISFACTORY AT THE TIME OF RELEASE. ALSO, 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 COMPLAINT TREND HAS BEEN IDENTIFIED FOR PH VARIANCE OR CONTAMINATION. NO RETENTION SAMPLES WERE AVAILABLE FOR INSPECTION. TESTING RECORDS WERE RECEIVED FOR INVESTIGATION: A CLSI STATEMENT FORM (INCLUDED WITH THE PRODUCT) WAS RECEIVED WITH A SHIPPING DATE OF MARCH 18, 2024 AND LISTING ONE 100 PACK CARTON OF BATCH: 4032739 TO PFIZER AT RD 689 KM 1.9; VEGA BAJA, PR ONE TESTING RECORD REVIEWED ON MARCH 04, 2024 SHOWS SATISFACTORY RESULTS FOR GROWTH PROMOTION TESTING BUT UNSATISFACTORY RESULTS FOR THE STERILITY CHECK. A PRINTED PH SLIP SHOWS WITH A PH RESULT OF 5.879 DATED ON (B)(6) 2024. A PRINTED PH SLIP WITH BATCH NUMBER: 4032739 WRITTEN ON IT SHOWS A PH RESULT OF 5.948 DATED ON (B)(6) 2024. SAP SCREENSHOTS ALSO WERE RECEIVED: ONE SHOWS A RECORD OF 1 CASE OF (B)(4) WITH A DELIVERY DATE OF FEBRUARY 14, 2024 ONE SHOWS A RECORD OF 2 CASES OF (B)(4) WITH A DELIVERY DATE OF MARCH 21, 2024 ONE SHOWS ADDRESS DATA FOR VIATRIS PHARMACEUTICALS AT RD 689 KM 1.9; VEGA BAJA, PR THERE WERE NO BATCH NUMBERS SHOWN ON THE SAP SCREENSHOTS AND A DELIVERY DATE OF FEBRUARY 14, 2024 IS NOT POSSIBLE FOR BATCH: 4032739. BATCH: 4032739 WAS MANUFACTURED ON FEBRUARY 12, 2024 AND WAS NOT AVAILABLE TO BE SHIPPED TO CUSTOMERS ON FEBRUARY 14, 2024. A TOTAL OF 282 PLATES WERE RETURNED AS 28 SLEEVES (24 UNOPENED, AND 4 OPENED, PARTIAL) AND 3 LOOSE PLATES IN 100 PACK CARTONS WERE SHIPPED IN A BOX WITH PAPER PADDING AND BUBBLE WRAP. THE 24 UNOPENED SLEEVES WERE INCUBATED PRIOR TO INSPECTION AT 23 TO 27 DEGREES C (12 SLEEVES) AND 33 TO 37 DEGREES C (12 SLEEVES). PLATES WERE INSPECTED AT 3 DAYS INCUBATION AND 8/240 PLATES HAD FUNGAL GROWTH (TIME STAMPS 1826-1828, 1830). AFFECTED PLATES WERE SUBMITTED TO THE ID LAB AND RHIZOMUCOR SPECIES WAS IDENTIFIED. THE OTHER 42 PLATES RETURNED IN OPENED SLEEVES AND AS LOOSE PLATES DID NOT HAVE MICROBIAL GROWTH UPON INSPECTION (TIME STAMPS 1826 AND 1827). RETURNED PLATES WERE TESTED FOR PH AND WAS FOUND TO BE LOWER THAN SPECIFICATION OF 7.1 TO 7.5. HOWEVER, THE PLATES RETURNED WERE NOT MAINTAINED AT 2 TO 8 DEGREES C AS LABELED DURING RETURN SHIPMENT AND WERE TESTED AFTER THE BATCH EXPIRATION DUE TO DELAYS IN THE INVESTIGATION PROCESS. THE INVESTIGATION TEAM APOLOGIES FOR THE DELAY BUT BD MAKES NO CLAIMS ON EXPIRED PRODUCT AND NO FURTHER TESTING WAS CONDUCTED. BECAUSE PH WAS TESTED AFTER EXPIRATION, THE TESTING IS NOT CONCLUSIVE TO CONFIRM PH VARIANCE. REVIEW OF MANUFACTURING RECORDS DID NOT SHOW ANY FORMULATION OR IN-PROCESS DEVIATIONS THAT WOULD CAUSE PH TO BE OUT OF SPECIFICATION. PH TESTING DURING QC RELEASE TESTING WAS WITHIN THE SPECIFICATION OF 7.1 TO 7.5. THIS COMPLAINT CANNOT BE CONFIRMED FOR PH VARIANCE. THIS COMPLAINT CAN BE CONFIRMED FOR CONTAMINATION. NO COMPLAINT TREND FOR CONTAMINATION HAS BEEN IDENTIFIED; NO ACTIONS ARE INDICATED AT THIS TIME. BD WILL CONTINUE TO TREND COMPLAINTS FOR DEFECTS.
H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
IT WAS REPORTED WHILE USING BD BBL¿ TRYPTICASE¿ SOY AGAR (SOYBEAN-CASEIN DIGEST AGAR) THAT THE PH OF THE MEDIA WAS OUT OF RANGE. THE CUSTOMER MEASURED THE PH USING A PROBE AND OBTAINED VALUES OF 5.879 AND 5.948. THIS IS LOWER THAN THE EXPECTED PH OF 7.0. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
IT WAS REPORTED WHILE USING BD BBL¿ TRYPTICASE¿ SOY AGAR (SOYBEAN-CASEIN DIGEST AGAR) THAT THE PH OF THE MEDIA WAS OUT OF RANGE. THE CUSTOMER MEASURED THE PH USING A PROBE AND OBTAINED VALUES OF 5.879 AND 5.948. THIS IS LOWER THAN THE EXPECTED PH OF 7.0. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 610925 | BD BBL¿ TRYPTICASE¿ SOY AGAR (SOYBEAN-CASEIN DIGEST AGAR) | CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL | JSG | BECTON DICKINSON & CO. (SPARKS) | 4032739 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |