BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ SABOURAUD DEXTROSE AGAR (DEEP FILL)

    MDR report key: 16948174 · Received May 17, 2023

    Report

    Report Number
    1119779-2023-00569
    Event Type
    Malfunction
    Date Received
    May 17, 2023
    Date of Event
    April 27, 2023
    Report Date
    August 31, 2023
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JSI
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: THIS MEMO IS TO SUMMARIZE FINDINGS REGARDING THE COMPLAINT RELATED TO CATALOG NUMBER 221278, PLATE SABOURAUD DEXTROSE AGAR 100 EA, BATCH NUMBER 3067379 AND BD COMPLAINT NUMBER (B)(4) FOR CONTAMINATION. DURING MANUFACTURING OF MATERIAL 221278, 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 3067379 IS 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 THE ONLY COMPLAINTS TAKEN ON BATCH 3067379 WERE FROM BAUSCH & LOMB PHARMACEUTICALS (COMPLAINT (B)(4) FOR BROKEN PLATES AND TORN SLEEVES AND COMPLAINT (B)(4) FOR CONTAMINATION). RETENTION SAMPLES FROM BATCH 3067379 WERE NOT AVAILABLE FOR INSPECTION. FIVE PHOTOS WERE RECEIVED FOR INVESTIGATION. ONE PHOTO SHOWS THE SIDE OF A SLEEVE FROM BATCH 3067379 WITH BROKEN PLATE LIDS AND PLASTIC PIECES IN THE SLEEVE. TWO PHOTOS EACH SHOWS THE BOTTOM OF A PLATE FROM BATCH 3067379 (TIME STAMP 2250) WITH WHAT APPEARS TO BE GROWTH AT THE EDGE OF THE MEDIA. THE LAST TWO PHOTOS EACH SHOW THE AGAR SURFACE OF A PLATE FROM BATCH 3067379 (TIME STAMP 2250) WITH GROWTH AT THE EDGE OF THE AGAR. IT APPEARS THE GROWTH HAS BEEN PICKED AT AS WELL. NO RETURN SAMPLES WERE RECEIVED FOR INVESTIGATION. THIS COMPLAINT CAN BE CONFIRMED FOR CONTAMINATION. BD HAS IDENTIFIED A CONTAMINATION TREND FOR THIS PRODUCT AND THE 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 PART OF THE IMPLEMENTATION WITH AN ONGOING TRAINING REVIEW FOR CLEANING PROCESSES. IMPROVEMENT IN OBSERVATION OF CONTAMINATION IS EXPECTED AS THE CAPA PROGRESSES. HOWEVER, THIS PRODUCT DOES NOT HAVE A STERILE CLAIM AND BD CANNOT ENSURE THAT THERE WILL BE NO CONTAMINATION OBSERVED IN ANY BATCH OF THIS PRODUCT. BD WILL CONTINUE TO TREND COMPLAINTS FOR CONTAMINATION.

    Additional Manufacturer Narrative · 0

    H.3. 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 · 0

    IT WAS REPORTED THAT ONE BD BBL¿ SABOURAUD DEXTROSE AGAR (DEEP FILL) SHOWS CONTAMINATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTS CONTAMINATION ON ONE PLATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ONE BD BBL¿ SABOURAUD DEXTROSE AGAR (DEEP FILL) SHOWS CONTAMINATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTS CONTAMINATION ON ONE PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    542786 BD BBL¿ SABOURAUD DEXTROSE AGAR (DEEP FILL) CULTURE MEDIA, SELECTIVE AND DIFFERENTIAL JSI BECTON, DICKINSON & CO. (SPARKS) 3067379

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown