BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ MACCONKEY II AGAR

    MDR report key: 12178133 · Received July 15, 2021

    Report

    Report Number
    1119779-2021-01182
    Event Type
    Malfunction
    Date Received
    July 15, 2021
    Date of Event
    June 16, 2021
    Report Date
    February 28, 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
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: 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 FOR BATCH: 1140579 WAS SATISFACTORY AT TIME OF RELEASE 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 NO OTHER COMPLAINTS HAVE BEEN TAKEN ON BATCH: 1140579. RETENTION SAMPLES FROM BATCH: 1140579 WERE NOT AVAILABLE. NO RETURN SAMPLES OR PHOTOS WERE RECEIVED FOR INVESTIGATION OF THIS COMPLAINT. IT IS ALSO UNCLEAR FROM THE DESCRIPTION WHICH LABEL WAS MISSING FROM THE PRODUCT IN QUESTION. THIS COMPLAINT CANNOT BE CONFIRMED. BD WILL CONTINUE TO TREND COMPLAINTS FOR LABELING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD BBL¿ MACCONKEY II AGAR A MISSING LABEL WAS OBSERVED BY THE LABORATORY PERSONNEL. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTING MISSING LABEL WITH PRODUCT 221270.

    Additional Manufacturer Narrative · 1

    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 · 1

    IT WAS REPORTED THAT WHILE USING BD BBL¿ MACCONKEY II AGAR A MISSING LABEL WAS OBSERVED BY THE LABORATORY PERSONNEL. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER REPORTING MISSING LABEL WITH PRODUCT 221270."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1071481 BD BBL¿ MACCONKEY II AGAR CULTURE MEDIA, SELECTIVE AND DIFFERENTIAL JSI BECTON, DICKINSON & CO. (SPARKS) 221270 1140579 10382902212703

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown