BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL SABOURAUD DEXTROSE AGAR

    MDR report key: 11598345 · Received March 31, 2021

    Report

    Report Number
    1119779-2021-00587
    Event Type
    Malfunction
    Date Received
    March 31, 2021
    Date of Event
    March 3, 2021
    Report Date
    September 16, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JSI
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 2021-03-24. H6: INVESTIGATION SUMMARY: THIS MEMO IS TO SUMMARIZE FINDINGS REGARDING THE COMPLAINT RELATED TO CATALOG NUMBER 221278, PLATE SABOURAUD DEXTROSE AGAR 100 EA, FOR BATCH NUMBER 1008384 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 1008384 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 COMPLAINTS HAVE BEEN TAKEN ON BATCH 1008384. RETENTION SAMPLES FROM BATCH 1008384 WERE NOT AVAILABLE FOR INSPECTION. RETURNS WERE RECEIVED FOR INVESTIGATION. ONE OPENED CARTON (100 PLATES) FROM BATCH 1008384 AND 2 SLEEVES (20 PLATES) FROM BATCH 1008384 WERE RETURNED IN A LARGE AND BOX WITH BUBBLE WRAP (CARTON 0138; TIME STAMPS 2348-2352, 0009). IT IS NOTED FOUR SLEEVES FROM BATCH 0316564 ALSO WERE RETURNED BUT WERE DETERMINED TO HAVE BEEN RETURNED IN ERROR AFTER FOLLOW UP. PRIOR TO INSPECTION, RETURNED SLEEVES FROM BATCH 1008384 WERE DIVIDED AND INCUBATED AT 20 TO 25 DEGREES C (6 SLEEVES) AND 33 TO 37 DEGREES C (6 SLEEVES). AT THREE DAYS INCUBATION, PLATES WERE INSPECTED AND 0/120 PLATES HAD MICROBIAL GROWTH. NO PHOTOS WERE RECEIVED FOR INVESTIGATION. THIS COMPLAINT CANNOT BE CONFIRMED. BD WILL CONTINUE TO TREND COMPLAINTS FOR INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER USE WITH BD BBL¿ SABOURAUD DEXTROSE AGAR 1 PLATE HAD MOLD GROWTH. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT MEDIA FAILED STERILITY. WHAT WERE THE NUMBER OF SAMPLES TESTED AND NUMBER OF SAMPLES THAT FAILED TESTING? 10 PLATES (1 SLEEVE ) AND 1 PLATE HAS MOLD GROWTH. WHAT WAS THE TIME STAMP ON THE MEDIA? LOT 1008384/0213/2021 06 07. WERE THE SAMPLES INCUBATED IN ORIGINAL WRAPPING OR REMOVED FROM WRAPPING PRIOR TO INCUBATION? INCUBATED IN ORIGINAL WRAPPING. WAS THE TEST PERFORMED IN HOOD, COUNTER OR CLEAN ROOM? TEST WAS PERFORMED FOR STERILITY TEST AND INCUBATED IN ORIGINAL WRAPPING. WHAT WAS THE INCUBATION TEMPERATURE AND TIME? 20-25 C FOR 7 DAYS. WAS THE GROWTH BACTERIAL OR FUNGAL? FUNGAL GROWTH. WAS IT SURFACE OR SUB-SURFACE GROWTH? SURFACE GROWTH. WHAT WAS THE LOCATION OF GROWTH ¿ EDGE OF PLATE OR MIDDLE? EDGE OF PLATE. WAS THE ORGANISM GRAM STAINED OR IDENTIFIED? 1 MOLD CFU. ORG WAS NOT SEND OUT FOR ID YET. IS THE PRODUCT AVAILABLE FOR RETURN? IF SO, ARE THE SLEEVES SEALED? THE PLATES ARE STILL IN OUR POSSESSION , SLEEVES ARE NOT IN ORIGINAL PACKAGING. ARE YOU REQUESTING FOR A REPLACEMENT? IF SO, PLEASE INDICATE THE NUMBER OF PLATES AFFECTED? YES. ARE YOU REQUESTING FOR AN INVESTIGATION FOLLOWUP? YES.

    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 AFTER USE WITH BD BBL¿ SABOURAUD DEXTROSE AGAR 1 PLATE HAD MOLD GROWTH. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT MEDIA FAILED STERILITY. WHAT WERE THE NUMBER OF SAMPLES TESTED AND NUMBER OF SAMPLES THAT FAILED TESTING? 10 PLATES (1 SLEEVE ) AND 1 PLATE HAS MOLD GROWTH. WHAT WAS THE TIME STAMP ON THE MEDIA? LOT 1008384/0213/(B)(6) 2021. WERE THE SAMPLES INCUBATED IN ORIGINAL WRAPPING OR REMOVED FROM WRAPPING PRIOR TO INCUBATION? INCUBATED IN ORIGINAL WRAPPING. WAS THE TEST PERFORMED IN HOOD, COUNTER OR CLEAN ROOM? TEST WAS PERFORMED FOR STERILITY TEST AND INCUBATED IN ORIGINAL WRAPPING. WHAT WAS THE INCUBATION TEMPERATURE AND TIME? 20-25 C FOR 7 DAYS. WAS THE GROWTH BACTERIAL OR FUNGAL? FUNGAL GROWTH. WAS IT SURFACE OR SUB-SURFACE GROWTH? SURFACE GROWTH. WHAT WAS THE LOCATION OF GROWTH ¿ EDGE OF PLATE OR MIDDLE? EDGE OF PLATE. WAS THE ORGANISM GRAM STAINED OR IDENTIFIED? 1 MOLD CFU. ORG WAS NOT SEND OUT FOR ID YET. IS THE PRODUCT AVAILABLE FOR RETURN? IF SO, ARE THE SLEEVES SEALED? THE PLATES ARE STILL IN OUR POSSESSION , SLEEVES ARE NOT IN ORIGINAL PACKAGING. ARE YOU REQUESTING FOR A REPLACEMENT? IF SO, PLEASE INDICATE THE NUMBER OF PLATES AFFECTED? YES. ARE YOU REQUESTING FOR AN INVESTIGATION FOLLOWUP? YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    493435 BD BBL SABOURAUD DEXTROSE AGAR CULTURE MEDIA, SELECTIVE AND DIFFERENTIAL JSI BECTON, DICKINSON & CO. (SPARKS) 1008384

    Patients

    Seq Age Sex Outcome Treatment
    1