BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ CHROMAGAR® MRSA II

    MDR report key: 22193787 · Received June 12, 2025

    Report

    Report Number
    1119779-2025-00572
    Event Type
    Malfunction
    Date Received
    June 12, 2025
    Date of Event
    June 6, 2025
    Report Date
    September 25, 2025
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    JSO
    UDI-DI
    10382902152290
    PMA / PMN Number
    K092767
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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. NO PHOTOS OR RETURNS WERE RECEIVED. 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

    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 1 OF 13: IT WAS REPORTED WHILE USING BD BBL¿ CHROMAGAR® MRSA II THAT ONE PATIENT SAMPLE OBTAINED FALSE S. AUREUS METHICILLIN RESISTANCE. THE SAMPLE WAS CONFIRMED TO BE METHICILLIN SUSCEPTIBLE BY PBP2A TESTING. QUALITY CONTROL TESTING FAILED, AND THE SHIPMENT WAS REMOVED FROM USE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Description of Event or Problem · 0

    REPORT 1 OF 13: IT WAS REPORTED WHILE USING BD BBL¿ CHROMAGAR® MRSA II THAT ONE PATIENT SAMPLE OBTAINED FALSE S. AUREUS METHICILLIN RESISTANCE. THE SAMPLE WAS CONFIRMED TO BE METHICILLIN SUSCEPTIBLE BY PBP2A TESTING. QUALITY CONTROL TESTING FAILED, AND THE SHIPMENT WAS REMOVED FROM USE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1972644 BD BBL¿ CHROMAGAR® MRSA II CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST, EXCLUDING MUELLER HINTON AGAR JSO BECTON DICKINSON & CO. (SPARKS) 5093285 10382902152290

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown