BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ MACCONKEY II AGAR

    MDR report key: 14360469 · Received May 11, 2022

    Report

    Report Number
    1119779-2022-00682
    Event Type
    Malfunction
    Date Received
    May 11, 2022
    Date of Event
    April 14, 2022
    Report Date
    September 1, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JSI
    UDI-DI
    10382902212703
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    DURING MANUFACTURING OF MATERIAL 221270, 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 REVIEW FOR BATCH 2033845 WAS SATISFACTORY AND NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND INSPECTION. THE RELEASE TESTING THAT IS PERFORMED ON THIS PRODUCT DOES INCLUDE PHYSICAL ATTRIBUTE TESTING. A SAMPLE OF PLATES ARE INCUBATED AT 25 DEGREES C AND AT 35 DEGREES C FOR APPROXIMATELY 72 HOURS. THEY ARE TESTED FOR PHYSICAL ATTRIBUTES PRIOR TO RELEASE TO ENSURE THAT THEY CONFORM TO PRODUCT SPECIFICATIONS. ALL PHYSICAL ATTRIBUTE TESTING PERFORMED ON THIS BATCH WAS SATISFACTORY PER BD INTERNAL PROCEDURES. THE COMPLAINT HISTORY WAS REVIEWED, AND TWO OTHER OTHER COMPLAINTS HAS BEEN TAKEN ON BATCH 2033845 FOR CONTAMINATION. RETENTION SAMPLES FROM BATCH 2033845 WERE NOT AVAILABLE FOR INVESTIGATION. THERE WERE NO PHOTOS AVAILABLE FOR REVIEW OF THIS COMPLAINT. NO RETURN SAMPLES WERE RECEIVED FOR INVESTIGATION. THIS COMPLAINT CANNOT BE CONFIRMED FOR CONTAMINATION. NO COMPLAINT TREND HAS BEEN IDENTIFIED FOR DEFECTS FOR THIS PRODUCT; NO ACTIONS ARE INDICATED AT THIS TIME. BD WILL CONTINUE TO TREND COMPLAINTS FOR CONTAMINATION.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT THE BD BBL¿ MACCONKEY II AGAR HAS BEEN FOUND CONTAINING BIOLOGICAL CONTAMINATION. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: PER THE CUSTOMER, RECEIVING MACONKEY AGAR WITH CONTAMINATION OF THE GRAM NEGATIVE RODS. CUSTOMER SAID THAT THEY DID NOT CULTURE THE ORGANISM. PLATES GREW A LACTOSE FERMENTING GRAM NEGATIVE ROD. PLATES WERE DISCARDED AND NO PHOTOS ARE AVAILABLE.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT THE BD BBL¿ MACCONKEY II AGAR HAS BEEN FOUND CONTAINING BIOLOGICAL CONTAMINATION. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: PER THE CUSTOMER, RECEIVING MACONKEY AGAR WITH CONTAMINATION OF THE GRAM NEGATIVE RODS CUSTOMER SAID THAT THEY DID NOT CULTURE THE ORGANISM. PLATES GREW A LACTOSE FERMENTING GRAM NEGATIVE ROD. PLATES WERE DISCARDED AND NO PHOTOS ARE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693968 BD BBL¿ MACCONKEY II AGAR CULTURE MEDIA, SELECTIVE AND DIFFERENTIAL JSI BECTON, DICKINSON & CO. (SPARKS) 221270 2033845 10382902212703

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown