BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ MACCONKEY II AGAR

    MDR report key: 14457379 · Received May 20, 2022

    Report

    Report Number
    1119779-2022-00724
    Event Type
    Malfunction
    Date Received
    May 20, 2022
    Date of Event
    April 25, 2022
    Report Date
    February 3, 2023
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JSI
    UDI-DI
    10382902212703
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY: DURING MANUFACTURING OF MATERIAL 221270, 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 2040749 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 2040749. RETENTION SAMPLES FROM BATCH 2040749 WERE NOT AVAILABLE FOR INSPECTION. TWO PHOTOS WERE RECEIVED FOR INVESTIGATION. ONE PHOTO SHOWS THE BOTTOM OF A PLATE FROM BATCH 2040749 (TIME STAMP 0856) WITH THE PLATE PRINT FEATURED FOR BATCH VERIFICATION. THE OTHER PHOTO SHOWS THE BOTTOM OF A PLATE FROM BATCH 2040749 (TIME STAMP 0856) WITH MICROBIAL GROWTH. NO RETURN SAMPLES WERE RECEIVED FOR INVESTIGATION. THIS COMPLAINT CAN BE CONFIRMED FOR CONTAMINATION. BD HAS IDENTIFIED A CONTAMINATION TREND FOR THIS PRODUCT AND THE 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. IMPROVEMENT IN OBSERVATION OF CONTAMINATION IS EXPECTED AS THE CAPA PROGRESSES. BD WILL CONTINUE TO TREND COMPLAINTS FOR CONTAMINATION.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT THE PRODUCT, BD BBL¿ MACCONKEY II AGAR HAD CONTAMINATION. THERE WERE 8 OCCURRENCES IN THIS 1 EVENT. NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "CUSTOMER IS REPORTING CONTAMINATION WITH THEIR 221270 PLATES FROM LOT 2040749"

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT THE PRODUCT, BD BBL¿ MACCONKEY II AGAR HAD CONTAMINATION. THERE WERE 8 OCCURRENCES IN THIS 1 EVENT. NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "CUSTOMER IS REPORTING CONTAMINATION WITH THEIR 221270 PLATES FROM LOT 2040749."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    523217 BD BBL¿ MACCONKEY II AGAR CULTURE MEDIA, SELECTIVE AND DIFFERENTIAL JSI BECTON, DICKINSON & CO. (SPARKS) 221270 2040749 10382902212703

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown