BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL SABOURAUD DEXTROSE AGAR (DEEP FILL)

    MDR report key: 12268906 · Received August 3, 2021

    Report

    Report Number
    1119779-2021-01270
    Event Type
    Malfunction
    Date Received
    August 3, 2021
    Date of Event
    July 7, 2021
    Report Date
    September 19, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JSI
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 7/9/2021. H.6. INVESTIGATION: THIS IS TO SUMMARIZE FINDINGS REGARDING THE COMPLAINT RELATED TO CATALOG NUMBER 221278, PLATE SABOURAUD DEXTROSE AGAR 100 EA, FOR BATCH NUMBER 1140584 AND COMPLAINT # (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 1140584 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 NO OTHER COMPLAINT HAS BEEN TAKEN ON BATCH 1140584. RETENTION SAMPLES FROM BATCH 1140584 WERE NOT AVAILABLE FOR INSPECTION. RETURNS WERE RECEIVED FOR INVESTIGATION. ELEVEN PLATES FROM BATCH 1140584 WERE RETURNED AS ONE TAPED, LOOSE PLATE IN A ZIPLOCK BAG AND ONE UNOPENED SLEEVE IN A ZIPLOCK BAG SHIPPED IN AN INSULATED BOX WITH ICE PACKS (TIME STAMPS 0703 AND 0709). THE UNOPENED SLEEVE WAS INSPECTED, AND 0/10 PLATES HAD MICROBIAL GROWTH. FOR INVESTIGATION, INSPECTED PLATES WERE DIVIDED AND INCUBATED AT 20 TO 25 DEGREES C (5 PLATES) AND 33 TO 37 DEGREES C (5 PLATES). NO MICROBIAL GROWTH WAS OBSERVED AT 7 DAYS INCUBATION IN 10/10 PLATES. THE ONE LOOSE PLATE RETURNED HAD SURFACE FUNGAL GROWTH. THE PLATE WAS SUBMITTED TO THE ID LAB AND VERTICILLIUM SPECIES WAS IDENTIFIED. ONE PHOTO ALSO WAS RECEIVED FOR INVESTIGATION. THE PHOTO SHOWS THE AGAR SURFACE OF A PLATE FROM BATCH 1140584 (TIME STAMP 0703) WITH A FUNGAL COLONY GROWING. THIS COMPLAINT HAS BEEN CONFIRMED. BD WILL CONTINUE TO TREND COMPLAINTS FOR CONTAMINATION. THIS PRODUCT DOES NOT HAVE A STERILE CLAIM. BASED ON THE LOW DEFECT RATE FOR THIS BATCH, NO ACTIONS ARE PLANNED AT THIS TIME. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 4 BD BBL¿ SABOURAUD DEXTROSE AGAR (DEEP FILL) WERE CONTAMINATED. DURING STERILITY TEST, 2 MOLD COLONIES WERE DISPLAYED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER ALLEGES THAT THE PLATES SDA 221278_1140584 "DISPLAYED TWO MOLD COLONIES DURING A STERILITY ASSURANCE TEST (4 PLATES, 2 AT 30-35C AND 2 AT 20-25C, ARE INCUBATED WITHOUT OPENING THEM UP FOR 7 DAYS) THUS MAKING THIS TEST FAIL THE BATCH TESTING CRITERIA.".

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 4 BD BBL¿ SABOURAUD DEXTROSE AGAR (DEEP FILL) WERE CONTAMINATED. DURING STERILITY TEST, 2 MOLD COLONIES WERE DISPLAYED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER ALLEGES THAT THE PLATES SDA 221278_1140584 "DISPLAYED TWO MOLD COLONIES DURING A STERILITY ASSURANCE TEST (4 PLATES, 2 AT 30-35C AND 2 AT 20-25C, ARE INCUBATED WITHOUT OPENING THEM UP FOR 7 DAYS) THUS MAKING THIS TEST FAIL THE BATCH TESTING CRITERIA."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1165805 BD BBL SABOURAUD DEXTROSE AGAR (DEEP FILL) CULTURE MEDIA, SELECTIVE AND DIFFERENTIAL JSI BECTON, DICKINSON & CO. (SPARKS) 1140584

    Patients

    Seq Age Sex Outcome Treatment
    1