BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL MACCONKEY II AGAR

    MDR report key: 11649710 · Received April 12, 2021

    Report

    Report Number
    1119779-2021-00649
    Event Type
    Malfunction
    Date Received
    April 12, 2021
    Date of Event
    March 14, 2021
    Report Date
    September 18, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JSI
    UDI-DI
    10382902212703
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 0365626 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 BIOBURDEN TESTING. A SAMPLE OF PLATES ARE INCUBATED AT 25 DEGREES C AND AT 35 DEGREES C FOR APPROXIMATELY 72 HOURS. ALL BIOBURDEN TESTING PERFORMED ON THIS BATCH WAS SATISFACTORY PER BD INTERNAL PROCEDURES. AFFECTED PRODUCT DOES NOT HAVE ANY STERILITY CLAIMS; THE PRODUCT IS TESTED FOR BIOBURDEN PRIOR TO RELEASE TO ENSURE THAT IT CONFORMS TO PRODUCT SPECIFICATIONS. HOWEVER, THIS DOES NOT ENSURE THAT THE END-USER WILL NOT RECEIVE A CONTAMINATED PLATE. THE COMPLAINT HISTORY WAS REVIEWED, AND ONE OTHER COMPLAINT HAS BEEN TAKEN ON BATCH 0365626 FOR CONTAMINATION. RETENTION SAMPLES FROM BATCH 0365626 WERE NOT AVAILABLE FOR INSPECTION. THREE PHOTOS WERE RECEIVED FOR INVESTIGATION. ONE PHOTO SHOWS TWO PLATES FROM BATCH 0365626 (TIME STAMPS 0544 AND 0545) WITH ONE BACTERIAL COLONY GROWING IN EACH PLATE. THE OTHER TWO PHOTOS EACH SHOW THE SURFACE OF A PLATE WITH ONE SURFACE BACTERIA COLONY. NO RETURN SAMPLES WERE RECEIVED FOR INVESTIGATION. THIS COMPLAINT HAS BEEN CONFIRMED. BD WILL CONTINUE TO TREND COMPLAINTS FOR CONTAMINATION. BASED ON THE LOW DEFECT RATE FOR THIS BATCH, NO ACTIONS ARE PLANNED AT THIS TIME. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING 60 BD BBL¿ MACCONKEY II AGAR BIOLOGICAL FOREIGN MATTER WAS OBSERVED BY THE LABORATORY PERSONNEL. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " CUSTOMER PROBLEM: CUSTOMER REPORTING CONTAMINATED MEDIA CATALOG# 221270, LOT# 0365626 STEPS TAKEN WITH CUSTOMER/TROUBLESHOOTING: CUSTOMER STATES THAT THE PLATES ARE GROWING GRAM NEGATIVE BACILLI. PLATES STORED APPROPRIATELY. NO ISSUES WITH THE MEDIA WHEN SHIPPED TO FACILITY INITIALLY  ".

    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 60 BD BBL¿ MACCONKEY II AGAR BIOLOGICAL FOREIGN MATTER WAS OBSERVED BY THE LABORATORY PERSONNEL.THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " CUSTOMER PROBLEM: CUSTOMER REPORTING CONTAMINATED MEDIA CATALOG# 221270, LOT# 0365626 STEPS TAKEN WITH CUSTOMER/TROUBLESHOOTING: CUSTOMER STATES THAT THE PLATES ARE GROWING GRAM NEGATIVE BACILLI. PLATES STORED APPROPRIATELY. NO ISSUES WITH THE MEDIA WHEN SHIPPED TO FACILITY INITIALLY  "

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    545884 BD BBL MACCONKEY II AGAR CULTURE MEDIA, SELECTIVE AND DIFFERENTIAL JSI BECTON, DICKINSON & CO. (SPARKS) 221270 0365626 10382902212703

    Patients

    Seq Age Sex Outcome Treatment
    1