BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ CHROMAGAR® MRSA II

    MDR report key: 22731481 · Received August 6, 2025

    Report

    Report Number
    1119779-2025-02487
    Event Type
    Malfunction
    Date Received
    August 6, 2025
    Date of Event
    July 11, 2025
    Report Date
    September 25, 2025
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JSO
    PMA / PMN Number
    K092767
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED AND/OR ADDITIONAL INFORMATION. D4. MEDICAL DEVICE LOT#: 5093285. D4. MEDICAL DEVICE EXPIRATION DATE: 23-JUNE-2025. H4. DEVICE MANUFACTURE DATE: 03-APRIL-2025. D4. UNIQUE IDENTIFIER (UDI) #: (B)(4). INVESTIGATION SUMMARY: DURING MANUFACTURING OF MATERIAL 215229, 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 5093285 WAS SATISFACTORY AND NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND INSPECTION. ALL PERFORMANCE TESTING ON THIS BATCH WAS SATISFACTORY AT THE TIME OF RELEASE. 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 CHROMAGAR MRSA II IS STABILITY TESTED BIENNIALLY FOR BIOLOGICAL PERFORMANCE TO ENSURE PERFORMANCE IS SATISFACTORY THROUGHOUT SHELF LIFE WITH THE ORGANISMS THAT ARE REPORTED ON THE CERTIFICATE OF ANALYSIS. PHOTOS AND RETURNS WERE NOT RECEIVED FOR THIS INVESTIGATION. RETENTION SAMPLES WERE TESTED PER THE STANDARD PERFORMANCE PROCEDURE WHICH IS ALSO DESCRIBED IN THE IFU (INSTRUCTIONS FOR USE, AVAILABLE ON BD.COM/E-LABELING). TESTING CONDUCTED FOR THE INVESTIGATION HAS REPLICATED THE PERFORMANCE DEFECT. THIS COMPLAINT IS CONFIRMED. A TREND IN PERFORMANCE COMPLAINTS HAS BEEN IDENTIFIED FOR BATCH 5093285. BD HAS INITIATED A CAPA (CORRECTIVE AND PREVENTATIVE ACTION) TO FORMALLY INVESTIGATE THE PERFORMANCE ISSUE IDENTIFIED FOR BATCH 5093285. BD WILL CONTINUE TO TREND COMPLAINTS FOR PERFORMANCE.

    Additional Manufacturer Narrative · 0

    B3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THE INITIAL REPORTER PROVIDED MAY 2025 WITH NO FURTHER DATE INFORMATION. E4. FDA NOTIFIED: THE INITIAL REPORTER ALSO NOTIFIED THE FDA IN JULY 2025. NO FURTHER DATE INFORMATION IS AVAILABLE. MEDSUN REPORT # (B)(4). A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    REPORT 2 OF 85. IT WAS REPORTED WHILE USING BD BBL¿ CHROMAGAR® MRSA II, ONE (1) PATIENT ISOLATE RESULTED AS POSITIVE FOR METHICILLIN RESISTANT STAPHYLOCOCCUS AUREUS (MRSA). UPON PERFORMING GENOME SEQUENCING OF THE ISOLATE, IT WAS CONFIRMED THE PATIENT RESULT WAS SUSCEPTIBLE TO METHICILLIN. THERE WAS NO ADVERSE IMPACT REPORTED.

    Description of Event or Problem · 0

    REPORT 2 OF 85: IT WAS REPORTED WHILE USING BD BBL¿ CHROMAGAR® MRSA II, ONE (1) PATIENT ISOLATE RESULTED AS POSITIVE FOR METHICILLIN RESISTANT STAPHYLOCOCCUS AUREUS (MRSA). UPON PERFORMING GENOME SEQUENCING OF THE ISOLATE, IT WAS CONFIRMED THE PATIENT RESULT WAS SUSCEPTIBLE TO METHICILLIN. THERE WAS NO ADVERSE IMPACT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1726214 BD BBL¿ CHROMAGAR® MRSA II CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST, EXCLUDING MUELLER HINTON AGAR JSO BECTON, DICKINSON & CO. (SPARKS) 5093285

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown