BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 12277613 · Received August 4, 2021

    Report

    Report Number
    1119779-2021-01293
    Event Type
    Malfunction
    Date Received
    August 4, 2021
    Date of Event
    July 9, 2021
    Report Date
    March 4, 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
    TX, 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: 7/14/2021. H.6. INVESTIGATION: 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 1131745 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 1131745 FOR CONTAMINATION. RETENTION SAMPLES FROM BATCH 1131745 WERE NOT AVAILABLE FOR INSPECTION. NINE PLATES FROM BATCH 1131745 WERE RETURNED AS LOOSE PLATES IN A ZIPLOCK BAG SHIPPED IN AN INSULATED BOX WITH ICE PACKS (TIME STAMPS 1730, 1741 AND 1742). RETURN PLATES WERE INSPECTED AND 8/9 PLATES EACH HAD SURFACE AND SUBSURFACE MICROBIAL GROWTH IN BOTH MEDIA. ONE AFFECTED PLATE WAS SUBMITTED TO THE ID LAB AND PSEUDOMONAS FLUORESCENS WAS IDENTIFIED. ONE PHOTO ALSO WAS RECEIVED FOR INVESTIGATION. HOWEVER, THIS PHOTO SHOWS THE BOTTOM OF FOUR PLATES FROM BATCH 1141055 (TIME STAMPS 0037 AND 0039) WITH MEDIA SPLASH OVER FOR COMPLAINT 3292299. THIS COMPLAINT CAN BE CONFIRMED FOR CONTAMINATION. A TREND WAS IDENTIFIED FOR CONTAMINATION AND INVESTIGATION FOUND OPPORTUNITIES FOR BIOBURDEN REDUCTION IN THE MANUFACTURING PROCESS. CAPA#3076308 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. BD WILL CONTINUE TO TREND COMPLAINTS FOR CONTAMINATION. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 30 PLATES OF BD BBL¿ TRYPTICASE¿ SOY AGAR WITH 5% SHEEP BLOOD (TSA II) // MACCONKEY II AGAR WERE CONTAMINATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THERE IS CONTAMINATION.

    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 30 PLATES OF BD BBL¿ TRYPTICASE¿ SOY AGAR WITH 5% SHEEP BLOOD (TSA II) // MACCONKEY II AGAR WERE CONTAMINATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THERE IS CONTAMINATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1171174 BD BBL¿ TRYPTICASE¿ SOY AGAR W 5% SHEEP BLOOD (TSA II) MACCONKEY II AGAR CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL JSG BECTON, DICKINSON & CO. (SPARKS) 221291 1131745 10382902212918

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown