BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ SABOURAUD DEXTROSE AGAR (DEEP FILL)

    MDR report key: 12657196 · Received October 19, 2021

    Report

    Report Number
    1119779-2021-01675
    Event Type
    Malfunction
    Date Received
    October 19, 2021
    Date of Event
    September 22, 2021
    Report Date
    August 25, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JSI
    UDI-DI
    10382902211805
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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 221180, PLATE SABOURAUD DEXTROSE AGAR 20 EA, BATCH NUMBER 1238261 AND COMPLAINT NUMBER (B)(4). FOR MISSING LABEL. DURING MANUFACTURING OF MATERIAL 221180, 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 1238261 WAS SATISFACTORY AND NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND INSPECTION. THE RELEASE TESTING THAT IS PERFORMED ON THIS PRODUCT DOES INCLUDE PHYSICAL ATTRIBUTE TESTING. A SAMPLE OF PLATES ARE INCUBATED AT 25 DEGREES C AND AT 35 DEGREES C FOR APPROXIMATELY 72 HOURS. THEY ARE TESTED FOR PHYSICAL ATTRIBUTES PRIOR TO RELEASE TO ENSURE THAT THEY CONFORM TO PRODUCT SPECIFICATIONS. ALL PHYSICAL ATTRIBUTE TESTING PERFORMED ON THIS BATCH, INCLUDING SLEEVE ATTRIBUTES, WAS SATISFACTORY PER BD INTERNAL PROCEDURES. THE COMPLAINT HISTORY WAS REVIEWED, AND THE ONLY OTHER COMPLAINT ON BATCH 1238261 WAS ALSO FROM EVONIK FOR A DIFFERENT DEFECT (COMPLAINT NUMBER (B)(4). , MISSING PLATE). RETENTION SAMPLES FROM BATCH 1238261 WERE NOT AVAILABLE FOR INSPECTION. THREE PHOTOS WERE RECEIVED FOR INVESTIGATION. ONE PHOTO SHOWS THE TOP OF AN OPENED 20PACK CARTON. ANOTHER PHOTO SHOWS THE SIDE OF A CARTON FROM BATCH 1238261 (CARTON NUMBER 0101) WITH THE CARTON LABEL FEATURED FOR BATCH VERIFICATION. THE LAST PHOTO SHOWS TWO SLEEVES FROM BATCH 1238261 WITH ONE SLEEVE THAT HAS A SLEEVE LABEL AND ANOTHER SLEEVE THAT DOES NOT APPEAR TO HAVE A SLEEVE LABEL. NO RETURN SAMPLES WERE RECEIVED FOR THIS INVESTIGATION. THIS PRODUCT IS PACKAGED INTO SLEEVES AND LABELED VIA AN AUTOMATED PROCESS. IF A FAILURE IN THE SLEEVE LABELING PROCESS OCCURS, EACH PLATE OF THIS PRODUCT IS LABELED SO THE MEDIA TYPE, BATCH AND EXPIRATION DATE READILY AVAILABLE. THIS COMPLAINT CAN BE CONFIRMED. NO COMPLAINT TRENDS FOR LABELING DEFECTS HAVE BEEN IDENTIFIED FOR THIS PRODUCT; NO ACTIONS ARE INDICATED AT THIS TIME. BD WILL CONTINUE TO TREND COMPLAINTS FOR LABELING DEFECTS.

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD BBL¿ SABOURAUD DEXTROSE AGAR (DEEP FILL) EXPERIENCED MISSING LABEL INFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MISSING A LABEL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD BBL¿ SABOURAUD DEXTROSE AGAR (DEEP FILL) EXPERIENCED MISSING LABEL INFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MISSING A LABEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1552640 BD BBL¿ SABOURAUD DEXTROSE AGAR (DEEP FILL) CULTURE MEDIA, SELECTIVE AND DIFFERENTIAL JSI BECTON, DICKINSON & CO. (SPARKS) 221180 1238261 10382902211805

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown