BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ SABOURAUD DEXTROSE AGAR (DEEP FILL)

    MDR report key: 16035653 · Received December 22, 2022

    Report

    Report Number
    1119779-2022-01525
    Event Type
    Malfunction
    Date Received
    December 22, 2022
    Date of Event
    November 28, 2022
    Report Date
    April 21, 2023
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JSI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    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 NUMBERS 2270859, 2228660 AND 2178461 AND BD COMPLAINT NUMBER (B)(4) FOR CONTAMINATION AND AGAR BED FALLOUT. 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 RECORDS FOR BATCHES 2270859, 2228660 AND 2178461 WERE SATISFACTORY AND NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND INSPECTION OF EACH BATCH. THE RELEASE TESTING THAT IS PERFORMED ON THIS PRODUCT DOES INCLUDE PHYSICAL ATTRIBUTE AND BIOBURDEN TESTING. A SAMPLE OF PLATES ARE INCUBATED AT 25 DEGREES C AND AT 35 DEGREES C FOR APPROXIMATELY 72 HOURS. ALL PHYSICAL ATTRIBUTE AND 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 COMPLAINTS HAVE BEEN TAKEN ON BATCH 2270859, BATCH 2228660 OR BATCH 2178461. RETENTION SAMPLES FROM BATCHES 2270859, 2228660 AND 2178461 WERE NOT AVAILABLE FOR INSPECTION. THREE PLATES FROM BATCH 2270859 WERE RETURNED AS LOOSE, PARAFILMED PLATES IN A BIOHAZARD SHIPPING KIT. SURFACE FUNGAL GROWTH WAS OBSERVED ON 3/3 RETURNED PLATES (TIME STAMP 2339). AGAR BED FALLOUT WAS NOT OBSERVED IN THE RETURNED PLATES. ONE AFFECTED PLATE WAS SUBMITTED TO THE ID LAB AND PAECILOMYCES SPECIES WAS IDENTIFIED. NO RETURN SAMPLES FROM BATCH 2228660 OR BATCH 2178461 WERE RECEIVED. FIVE PHOTOS ALSO WERE RECEIVED FOR INVESTIGATION: ONE PHOTO SHOWS THE AGAR SURFACE OF THREE PLATES FROM BATCH 2270859 (TIME STAMP 2339) WITH FUNGAL GROWTH IN EACH PLATE. THREE PHOTOS EACH SHOW THE AGAR SURFACE OF A PLATE FROM BATCH 2270859 (TIME STAMP 2339) WITH FUNGAL GROWTH. ONE PHOTO SHOWS THE BOTTOM OF THREE PLATES FROM BATCH 2228660 (TIME STAMPS 1043 AND 1047) WITH THE AGAR BED IN EACH PLATE FALLEN OUT OF THE PLATE BOTTOM. NO PHOTOS SHOWING PLATES FROM BATCH 2170859 OR PLATES FROM BATCH 2270859 WITH AGAR BED FALLOUT WERE RECEIVED. THIS COMPLAINT CAN BE CONFIRMED FOR CONTAMINATION IN BATCH 2270859. THIS COMPLAINT CANNOT BE CONFIRMED FOR AGAR BED FALLOUT IN BATCH 2270859. THIS COMPLAINT CAN BE CONFIRMED FOR AGAR BED FALLOUT IN BATCH 2228660. THIS COMPLAINT CANNOT BE CONFIRMED FOR AGAR BED FALLOUT IN BATCH 2178461. NO COMPLAINT TRENDS FOR FUNGAL CONTAMINATION OR AGAR BED FALLOUT HAVE BEEN IDENTIFIED; NO ACTIONS ARE INDICATED AT THIS TIME. BD WILL CONTINUE TO TREND COMPLAINTS FOR CONTAMINATION AND AGAR BED FALLOUT. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    REPORT 3 OF 3: IT WAS REPORTED THAT BD BBL¿ SABOURAUD DEXTROSE AGAR (DEEP FILL) SEVERAL OCCURRENCES OF FUNGAL CONTAMINATION OCCURRED. NO INJURIES WERE REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THERE WERE 8 PLATES THAT WE FOUND HAD GROWTH ON THEM BEFORE THEY WERE OPENED. I JUST SENT OUT SAMPLES FOR IDENTIFICATION TODAY. THE FIRST TEST THAT WE DID HAD THREE GROW, THEN TWO MORE TESTS WERE COMPLETED AND THAT IS WHERE THE OTHER 5 WERE FOUND.

    Description of Event or Problem · 0

    REPORT 3 OF 3. IT WAS REPORTED THAT BD BBL¿ SABOURAUD DEXTROSE AGAR (DEEP FILL) SEVERAL OCCURRENCES OF FUNGAL CONTAMINATION OCCURRED. NO INJURIES WERE REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THERE WERE 8 PLATES THAT WE FOUND HAD GROWTH ON THEM BEFORE THEY WERE OPENED. I JUST SENT OUT SAMPLES FOR IDENTIFICATION TODAY. THE FIRST TEST THAT WE DID HAD THREE GROW, THEN TWO MORE TESTS WERE COMPLETED AND THAT IS WHERE THE OTHER 5 WERE FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2858463 BD BBL¿ SABOURAUD DEXTROSE AGAR (DEEP FILL) CULTURE MEDIA, SELECTIVE AND DIFFERENTIAL JSI BECTON, DICKINSON & CO. (SPARKS) 2270859

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown