BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ MACCONKEY II AGAR

    MDR report key: 12025875 · Received June 18, 2021

    Report

    Report Number
    1119779-2021-01007
    Event Type
    Malfunction
    Date Received
    June 18, 2021
    Date of Event
    May 20, 2021
    Report Date
    November 8, 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
    ID, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: 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 1092958 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 ONE OTHER COMPLAINT HAS BEEN TAKEN ON BATCH 1092958 FOR CONTAMINATION AND SPLIT AGAR. RETENTION SAMPLES FROM BATCH 1092958 WERE NOT AVAILABLE FOR INSPECTION. RETURNS WERE RECEIVED FOR INVESTIGATION. SIXTEEN LOOSE PLATES FROM BATCH 1092958 IN ZIPLOCK BAGS WERE RETURNED IN A BOX WITH AIR BUBBLES (TIME STAMPS 0607-0615, 0617, 0618). SPLIT AGAR WAS SEEN IN 12/16 PLATES RETURNED AND SURFACE BACTERIAL GROWTH WAS SEEN ON 5/16 PLATES RETURNED. ONE AFFECTED PLATE WAS SUBMITTED TO THE ID LAB AND PSEUDOMONAS FLUORESCENS WAS IDENTIFIED. FIVE PHOTOS ALSO WERE RECEIVED FOR INVESTIGATION. THE PHOTO SHOWS THE BOTTOM OF SEVEN PLATES FROM BATCH 1092858 (TIME STAMPS NOT READABLE) WITH A SPLIT IN EACH AGAR BED. ONE PHOTO SHOWS THE PROFILE OF A PLATE WITH MICROBIAL GROWTH VISIBLE. ANOTHER PHOTO SHOWS THE BOTTOM OF A PLATE FROM BATCH 1092958 (TIME STAMP 0614) WITH A SPLIT IN THE AGAR BED AND MICROBIAL GROWTH. THE FOURTH PHOTO SHOWS THE BOTTOM OF A PLATE FROM BATCH 1092958 (TIME STAMP 0615) WITH A SPLIT IN THE AGAR BED. THE LAST PHOTO SHOWS THE PROFILE OF A PLATE. THIS COMPLAINT CAN BE CONFIRMED. BASED ON THE LOW DEFECT RATE FOR THIS BATCH; NO ACTIONS ARE PLANNED AT THIS TIME. BD WILL CONTINUE TO TREND COMPLAINTS FOR CONTAMINATION AND AGAR DEFECTS. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING 15 BD BBL¿ MACCONKEY II AGAR CONTAMINATION 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: "IT WAS REPORTED THAT CUSTOMER REPORTED CONTAMINATION AND MEDIA CUT OUT 221270 LOT 1092958."

    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 15 BD BBL¿ MACCONKEY II AGAR CONTAMINATION 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: " IT WAS REPORTED THAT CUSTOMER REPORTED CONTAMINATION AND MEDIA CUT OUT 221270 LOT 1092958. "

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    923958 BD BBL¿ MACCONKEY II AGAR CULTURE MEDIA, SELECTIVE AND DIFFERENTIAL JSI BECTON, DICKINSON & CO. (SPARKS) 221270 1092958 10382902212703

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown