BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ CHROMAGAR¿ ORIENT/TSA II W/5% SB

    MDR report key: 23221774 · Received October 6, 2025

    Report

    Report Number
    1119779-2025-05041
    Event Type
    Malfunction
    Date Received
    October 6, 2025
    Date of Event
    September 20, 2025
    Report Date
    October 29, 2025
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    JSH
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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: 22-OCT-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 5182834 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. PLATE BI CHROMAGAR ORIENTATION// TSA W/ 5% SB 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. THE COMPLAINT HISTORY WAS REVIEWED, AND NO OTHER COMPLAINTS HAVE BEEN TAKEN ON BATCH 5182834. RETENTION SAMPLES FROM BATCH 5182834 WERE NOT AVAILABLE FOR INSPECTION. TWO PHOTOS WERE PROVIDED FOR THIS INVESTIGATION; BOTH PHOTOS SHOW PICTURES OF A SINGLE PLATE (CHROMAGAR ORIENTATION// TSA W/ 5% SB) THAT HAS BEEN INOCULATED. NO GROWTH CAN BE SEEN ON THE CHROMAGAR SIDE. CONCLUSIONS ON PERFORMANCE CANNOT BE MADE FROM PHOTOS. RETURNS WERE PROVIDED FOR THIS INVESTIGATION; ONE UNOPEN SLEEVE FROM BATCH 5182834. ONE PLATE WAS PERFORMANCE TESTED FOR RECOVERY OF ATCC 25922 (E. COLI). THE RESULTS WERE SATISFACTORY PER BD INTERNAL PROCEDURES. THIS COMPLAINT CANNOT BE CONFIRMED DUE TO LACK OF EVIDENCE. NO COMPLAINT TREND FOR PERFORMANCE ISSUES HAS BEEN IDENTIFIED; NO ACTIONS ARE INDICATED AT THIS TIME. BD WILL CONTINUE TO TREND COMPLAINTS FOR DEFECTS.

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    REPORT 7 OF 9. IT WAS REPORTED THAT WHILE USING BD BBL¿ CHROMAGAR¿ ORIENT/TSA II W/5% SB, THE CUSTOMER NOTICED E.COLI DID NOT GROW ON CHROMOAGAR SIDE OF PLATE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Description of Event or Problem · 0

    REPORT 7 OF 9: IT WAS REPORTED THAT WHILE USING BD BBL¿ CHROMAGAR¿ ORIENT/TSA II W/5% SB, THE CUSTOMER NOTICED E.COLI DID NOT GROW ON CHROMOAGAR SIDE OF PLATE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608948 BD BBL¿ CHROMAGAR¿ ORIENT/TSA II W/5% SB CULTURE MEDIA, NON-SELECTIVE AND DIFFERENTIAL JSH BECTON DICKINSON & CO. (SPARKS) 5182834

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown