BD BBL¿ CHROMAGAR¿ ORIENT/TSA II W/5% SB
Report
- Report Number
- 1119779-2025-05559
- Event Type
- Malfunction
- Date Received
- January 13, 2026
- Date of Event
- December 23, 2025
- Report Date
- February 9, 2026
- Manufacturer
- BECTON DICKINSON & CO. (SPARKS)
- Product Code
- JSH
- UDI-DI
- 10382902222399
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. E1: INITIAL REPORTER ADDITIONAL PHONE # (B)(6).
THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED AND/OR ADDITIONAL INFORMATION. D9: DEVICE AVAILABLE FOR EVALUATION: YES. D9: RETURNED TO MANUFACTURER ON: 24-DEC-2025. INVESTIGATION SUMMARY: DURING MANUFACTURING OF MATERIAL 222239, 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 5293025 WAS SATISFACTORY AND NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND INSPECTION. ALL BATCHES ARE TESTED PRIOR TO RELEASE AND RESULTS REPORTED ON THE CERTIFICATE OF ANALYSIS WHICH CAN BE OBTAINED AT WWW.BD.COM/REGDOCS. MATERIAL 222239 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 FOR BATCH 5293025 WAS SATISFACTORY AT THE TIME OF RELEASE. NO RETENTION SAMPLES WERE AVAILABLE FOR INVESTIGATION OF THIS COMPLAINT. NO PHOTOS WERE AVAILABLE TO ASSIST WITH THE INVESTIGATION OF THIS COMPLAINT. ONE SEALED SLEEVE (10 PLATES) OF BATCH 5293025 WAS RETURNED TO ASSIST WITH THIS INVESTIGATION. THE RETURNED SAMPLE WAS PERFORMANCE TESTED FOR GROWTH RECOVERY AND REACTION COLOR FOR THE ORGANISMS OUTLINED IN THE COA. THE RESULTS WERE SATISFACTORY PER BD INTERNAL PROCEDURES. THIS COMPLAINT CANNOT BE CONFIRMED FOR NO OR FALSE REACTION. TESTING OF RETURNED SAMPLES PRODUCED SATISFACTORY RESULTS PER INTERNAL PROCEDURES. THE COMPLAINT HISTORY WAS REVIEWED, AND NO COMPLAINT TRENDS FOR THIS DEFECT HAVE BEEN IDENTIFIED FOR THIS PRODUCT; NO ACTIONS ARE INDICATED AT THIS TIME. BD WILL CONTINUE TO TREND COMPLAINTS FOR DEFECTS.
REPORT 1 OF 2. IT WAS REPORTED THAT WHILE USING ONE BD BBL¿ CHROMAGAR¿ ORIENT/TSA II W/5% SB, THE CUSTOMER NOTICED MEDIUM SIZED, DARK ROSE TO PINK, TRANSPARENT COLONIES THAT WERE ORIGINALLY THOUGHT TO BE E. COLI, BUT MALDI CONFIRMED AS CITROBACTER. THE CITROBACTER WAS RELEASED TO PHYSICIAN BUT WAS LATER CORRECTED TO E. COLI. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
REPORT 1 OF 2. IT WAS REPORTED THAT WHILE USING ONE BD BBL¿ CHROMAGAR¿ ORIENT/TSA II W/5% SB, THE CUSTOMER NOTICED MEDIUM SIZED, DARK ROSE TO PINK, TRANSPARENT COLONIES THAT WERE ORIGINALLY THOUGHT TO BE E. COLI, BUT MALDI CONFIRMED AS CITROBACTER. THE CITROBACTER WAS RELEASED TO PHYSICIAN BUT WAS LATER CORRECTED TO E. COLI. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 116454 | BD BBL¿ CHROMAGAR¿ ORIENT/TSA II W/5% SB | CULTURE MEDIA, NON-SELECTIVE AND DIFFERENTIAL | JSH | BECTON DICKINSON & CO. (SPARKS) | 5293025 | 10382902222399 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |