BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ TRYPTICASE¿ SOY AGAR WITH 5% SHEEP BLOOD (TSA II) // MACCONKEY II AGAR

    MDR report key: 12593101 · Received October 7, 2021

    Report

    Report Number
    1119779-2021-01617
    Event Type
    Malfunction
    Date Received
    October 7, 2021
    Date of Event
    September 9, 2021
    Report Date
    July 18, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JSG
    UDI-DI
    10382902212918
    PMA / PMN Number
    PREAMENDMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY : DURING MANUFACTURING OF MATERIAL 221291, 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 1181424 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 ON BATCH 1181424. RETENTION SAMPLES FROM BATCH 1181424 WERE NOT AVAILABLE FOR INSPECTION. TWO PHOTOS WERE RECEIVED FOR INVESTIGATION. ONE PHOTO SHOWS THE BOTTOM OF A PLATE FROM BATCH 1181424 (TIME STAMP 0801) WITH MICROBIAL GROWTH IN THE MACCONKEY AGAR. THE OTHER PHOTO SHOWS THE BOTTOM OF A PLATE FROM BATCH 1191424 (TIME STAMP 1049) WITH MICROBIAL GROWTH VISIBLE IN THE TSA WITH 5% SB AGAR. NO RETURN SAMPLES WERE RECEIVED FOR INVESTIGATION. THIS COMPLAINT CAN BE CONFIRMED BY THE PHOTOS PROVIDED. A TREND WAS IDENTIFIED FOR CONTAMINATION AND INVESTIGATION FOUND OPPORTUNITIES FOR BIOBURDEN REDUCTION IN THE MANUFACTURING PROCESS. A CAPA (CORRECTIVE AND PREVENTATIVE ACTIONS) HAS BEEN INITIATED AND INVOLVES IMPLEMENTING ADDITIONAL CLEANING EVENTS AND EVALUATION OF MANUFACTURING PROCEDURES FOCUSED ON IN-PROCESS BIOBURDEN REDUCTION. ADDITIONAL TRAININGS ARE PLANNED WITH AN ONGOING TRAINING REVIEW FOR CLEANING PROCESSES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BACTERIAL CONTAMINATION WAS DISCOVERED BEFORE AND AFTER INOCULATION WITH 15 BD BBL¿ TRYPTICASE¿ SOY AGAR WITH 5% SHEEP BLOOD (TSA II) // MACCONKEY II AGAR. CONTAMINATION WAS NOT IDENTIFIED AND THERE WAS NO REPORTED IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER NOTED THE CONTAMINATION WAS BACTERIA. CONTAMINATION WAS NOTICED BEFORE AND AFTER INOCULATION. NO PATIENT RESULTS WERE REPORTED WITH CONTAMINATION, THEY WERE REPEATED. CONTAMINATION WAS NOT IDENTIFIED, IT WAS PINK COLOR AND LACTOSE FERMENTER AND NOTICED AT THE EDGES OF THE PLATES. PLATES ARE STILL IN USE AND DO NOT HAVE ANY FOR RETURN.

    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 BACTERIAL CONTAMINATION WAS DISCOVERED BEFORE AND AFTER INOCULATION WITH 15 BD BBL¿ TRYPTICASE¿ SOY AGAR WITH 5% SHEEP BLOOD (TSA II) // MACCONKEY II AGAR. CONTAMINATION WAS NOT IDENTIFIED AND THERE WAS NO REPORTED IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER NOTED THE CONTAMINATION WAS BACTERIA. CONTAMINATION WAS NOTICED BEFORE AND AFTER INOCULATION. NO PATIENT RESULTS WERE REPORTED WITH CONTAMINATION, THEY WERE REPEATED. CONTAMINATION WAS NOT IDENTIFIED, IT WAS PINK COLOR AND LACTOSE FERMENTER AND NOTICED AT THE EDGES OF THE PLATES. PLATES ARE STILL IN USE AND DO NOT HAVE ANY FOR RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1488594 BD BBL¿ TRYPTICASE¿ SOY AGAR WITH 5% SHEEP BLOOD (TSA II) // MACCONKEY II AGAR CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL JSG BECTON, DICKINSON & CO. (SPARKS) 221291 1181424 10382902212918

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown