BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ TRYPTICASE¿ SOY AGAR (SOYBEAN-CASEIN DIGEST AGAR)

    MDR report key: 12249080 · Received July 29, 2021

    Report

    Report Number
    1119779-2021-01236
    Event Type
    Malfunction
    Date Received
    July 29, 2021
    Date of Event
    June 30, 2021
    Report Date
    November 24, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JSG
    UDI-DI
    10382902212833
    PMA / PMN Number
    PREAMENDMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVAL?: YES. D.9. RETURNED TO MANUFACTURER ON: 7/9/2021. H.6. INVESTIGATION: THIS STATEMENT IS TO SUMMARIZE FINDINGS REGARDING THE COMPLAINT RELATED TO CATALOG NUMBER 221283, PLATE TRYPTICASE SOY AGAR 100 EA, BATCH NUMBER 1146024 AND COMPLAINT NUMBER (B)(4) FOR CONTAMINATION. DURING MANUFACTURING OF MATERIAL 221283, 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 1146024 WAS 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 NO OTHER COMPLAINTS HAVE BEEN TAKEN FOR BATCH 1146024. RETENTION SAMPLES FROM BATCH 1146024 WERE NOT AVAILABLE FOR INSPECTION. RETURN SAMPLES WERE RECEIVED FOR INVESTIGATION. TWO UNOPENED SLEEVES (20 PLATES) FROM BATCH 1146024 WERE RETURNED IN AN INSULATED BOX WITH ICE PACKS AND BUBBLE WRAP. PLATES WERE INSPECTED, AND 0/20 PLATES HAD MICROBIAL GROWTH AT INITIAL INSPECTION (TIME STAMP 2057). FOR INVESTIGATION, PLATES WERE INCUBATED AT 20 TO 25 DEGREES C (10 PLATES) AND 33 TO 37 DEGREES C (10 PLATES) AND 0/20 PLATES HAD MICROBIAL GROWTH AT 5 DAYS INCUBATION. THREE PHOTOS ALSO WERE RECEIVED FOR INVESTIGATION. ONE PHOTO SHOWS THE BOTTOM OF THREE PLATES FROM BATCH 1146024 (TIME STAMP 2044); EACH PLATE IS LABELED AS "NEG CONTR" AND HAS AT LEAST ONE MICROBIAL COLONY GROWING. THE OTHER TWO PHOTOS EACH SHOW THE AGAR SURFACE OF ONE OR TWO PLATES FROM BATCH 1146024 (TIME STAMP 2044) WITH WHAT APPEARS TO BE AT LEAST ONE FUNGAL COLONY ON EACH PLATE. THIS COMPLAINT CAN BE CONFIRMED BY THE PHOTOS PROVIDED. THIS PRODUCT IS NOT LABELED STERILE. BASED ON THE LOW DEFECT RATE FOR THIS BATCH, NO ACTIONS ARE PLANNED AT THIS TIME. BD WILL CONTINUE TO TREND COMPLAINTS FOR CONTAMINATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD BBL¿ TRYPTICASE¿ SOY AGAR (SOYBEAN-CASEIN DIGEST AGAR) 4 PLATES WERE DISCOVERED TO HAVE FUNGAL CONTAMINATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER IS REPORTING CONTAMINATION WITH 221283 PLATES, LOT 1146024. THE FOUND GROWTH ON 4 PLATES THAT WERE INCUBATED FOR STERILITY VERIFICATION. THE PLATES WERE INCUBATED AT 30-35DEGREES C FOR 5 DAYS. WHEN THE LOT WAS RECEIVED NO ISSUES WHERE VISUALLY NOTICED. MEDIA WAS STORED IN REFRIGERATOR IN SLEEVES UNTIL USE. BACTERIA OR FUNGI? FUNGI ON THE SURFACE OR SUB-SURFACE? SURFACE WAS THE ORGANISM STAINED OR IDENTIFIED?: NO. *WERE ANY ERRANT RESULTS REPORTED DUE TO THE CONTAMINATION?: YES. *WERE ANY PATIENT RESULTS AFFECTED DUE TO THE CONTAMINATION?: NO.

    Additional Manufacturer Narrative · 1

    H.3. 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 WHILE USING BD BBL¿ TRYPTICASE¿ SOY AGAR (SOYBEAN-CASEIN DIGEST AGAR) 4 PLATES WERE DISCOVERED TO HAVE FUNGAL CONTAMINATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER IS REPORTING CONTAMINATION WITH 221283 PLATES, LOT 1146024. THE FOUND GROWTH ON 4 PLATES THAT WERE INCUBATED FOR STERILITY VERIFICATION. THE PLATES WERE INCUBATED AT 30-35DEGREES C FOR 5 DAYS. WHEN THE LOT WAS RECEIVED NO ISSUES WHERE VISUALLY NOTICED. MEDIA WAS STORED IN REFRIGERATOR IN SLEEVES UNTIL USE. BACTERIA OR FUNGI? FUNGI. ON THE SURFACE OR SUB-SURFACE? SURFACE. WAS THE ORGANISM STAINED OR IDENTIFIED? NO. WERE ANY ERRANT RESULTS REPORTED DUE TO THE CONTAMINATION? YES. WERE ANY PATIENT RESULTS AFFECTED DUE TO THE CONTAMINATION? NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1141213 BD BBL¿ TRYPTICASE¿ SOY AGAR (SOYBEAN-CASEIN DIGEST AGAR) CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL JSG BECTON, DICKINSON & CO. (SPARKS) 221283 1146024 10382902212833

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown