BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ MACCONKEY II AGAR

    MDR report key: 13046232 · Received December 20, 2021

    Report

    Report Number
    1119779-2021-01995
    Event Type
    Malfunction
    Date Received
    December 20, 2021
    Date of Event
    November 24, 2021
    Report Date
    October 3, 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
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    H.6 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 1294997 WAS SATISFACTORY 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 TWO OTHER COMPLAINTS HAVE BEEN TAKEN ON BATCH 1294997 FOR CONTAMINATION. RETENTION SAMPLES FROM BATCH 1294997 WERE NOT AVAILABLE FOR INSPECTION. THIRTY PLATES FROM BATCH 1294997 WERE RETURNED AS THREE UNOPENED SLEEVES SHIPPED IN A BOX WITH AIR BUBBLES, PAPER PADDING AND ICE PACKS. PLATES WERE INSPECTED AND 16/30 PLATES HAD SURFACE BACTERIAL GROWTH (TIME STAMPS 0751, 0804 AND 0815). ONE AFFECTED PLATE WAS SUBMITTED TO THE ID LAB AND PSEUDOMONAS FLUORESCENS WAS IDENTIFIED. TWO PHOTOS ALSO WERE RECEIVED FOR INVESTIGATION. ONE PHOTO SHOWS THE AGAR SURFACE OF A PLATE FROM BATCH 1294997 (TIME STAMP 0803) WITH SURFACE BACTERIA GROWTH. THE OTHER PHOTO SHOWS THE BOTTOM OF A PLATE FROM BATCH 1294997 (TIME STAMP 0803) WITH THE PLATE PRINT FEATURED FOR BATCH VERIFICATION. THIS COMPLAINT CAN BE CONFIRMED. A TREND WAS IDENTIFIED FOR CONTAMINATION AND INVESTIGATION FOUND OPPORTUNITIES FOR BIOBURDEN REDUCTION IN THE MANUFACTURING PROCESS. A CAPA (CORRECTIVE AND PREVENTATIVE ACTIONS) HAS BEEN INITIATED AND INVOLVES IMPLEMENTING ADDITIONAL CLEANING EVENTS AND EVALUATION OF MANUFACTURING PROCEDURES FOCUSED ON IN-PROCESS BIOBURDEN REDUCTION. ADDITIONAL TRAININGS ARE PLANNED WITH AN ONGOING TRAINING REVIEW FOR CLEANING PROCESSES. BD WILL CONTINUE TO TREND COMPLAINTS FOR CONTAMINATION. CAPA #3076308. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USE WITH BD BBL¿ MACCONKEY II AGAR VISISBLE CONTAMINATION WAS DISCOVERED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER IS REPORTING CONTAMINATION WITH THEIR 221270 PLATES FROM LOT 1294997. THEY STATED THEY RECEIVED 10 BOXES AND ALL HAD VISIBLE CONTAMINATION GROWTH ON SEVERAL SLEEVES FROM EACH BOX.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USE WITH BD BBL¿ MACCONKEY II AGAR VISISBLE CONTAMINATION WAS DISCOVERED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER IS REPORTING CONTAMINATION WITH THEIR 221270 PLATES FROM LOT 1294997. THEY STATED THEY RECEIVED 10 BOXES AND ALL HAD VISIBLE CONTAMINATION GROWTH ON SEVERAL SLEEVES FROM EACH BOX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1945649 BD BBL¿ MACCONKEY II AGAR CULTURE MEDIA, SELECTIVE AND DIFFERENTIAL JSI BECTON, DICKINSON & CO. (SPARKS) 221270 1294997 10382902212703

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown