BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ HEKTOEN ENTERIC AGAR

    MDR report key: 12125047 · Received July 6, 2021

    Report

    Report Number
    1119779-2021-01132
    Event Type
    Malfunction
    Date Received
    July 6, 2021
    Date of Event
    June 9, 2021
    Report Date
    December 14, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JSI
    UDI-DI
    10382902213656
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY DURING MANUFACTURING OF MATERIAL 221365, 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 1099191 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 OTHER COMPLAINTS HAVE BEEN TAKEN ON BATCH 1099191 FOR CONTAMINATION FROM OTHER CUSTOMERS. RETENTION SAMPLES FROM BATCH 1099191 WERE NOT AVAILABLE FOR INSPECTION. TEN PLATES FROM BATCH 1099191 WERE RETURNED AS ONE UNOPENED SLEEVE IN A ZIPLOCK BAG SHIPPED IN A BOX WITH AIR BUBBLES (TIME STAMP 1358). PLATES WERE INSPECTED AND SURFACE BACTERIAL GROWTH WAS OBSERVED IN 5/10 RETURNED PLATES. ONE PLATE WAS SUBMITTED TO THE ID LAB AND PSEUDOMONAS FLUORESCENS WAS IDENTIFIED. FOUR PHOTOS ALSO WERE RECEIVED FOR INVESTIGATION. THREE PHOTOS EACH SHOW THE AGAR SURFACE OF A OPENED PLATE FROM BATCH 1099191 (TIME STAMP 1358) WITH SURFACE BACTERIAL GROWTH. ONE PHOTO SHOWS THE BOTTOM OF A PLATE FROM BATCH 1099191 (TIME STAMP 1358) WITH A MICROBIAL COLONY GROWING. THIS COMPLAINT CAN BE CONFIRMED. A TREND WAS IDENTIFIED FOR CONTAMINATION AND INVESTIGATION FOUND OPPORTUNITIES FOR BIOBURDEN REDUCTION IN THE MANUFACTURING PROCESS. A CAPA (CORRECTIVE AND PREVENTATIVE ACTIONS) 3076308 HAS BEEN INITIATED AND INVOLVES IMPLEMENTING ADDITIONAL CLEANING EVENTS AND EVALUATION OF MANUFACTURING PROCEDURES FOCUSED ON IN-PROCESS BIOBURDEN REDUCTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING 40 BD BBL¿ HEKTOEN ENTERIC AGAR CONTAMINATION WAS OBSERVED BY THE LABORATORY PERSONNEL. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " IT WAS REPORTED THAT CUSTOMER HAS CONTAMINATION WITH 221365 PLATES LOT 1099919 "

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING 40 BD BBL¿ HEKTOEN ENTERIC AGAR CONTAMINATION WAS OBSERVED BY THE LABORATORY PERSONNEL. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT CUSTOMER HAS CONTAMINATION WITH 221365 PLATES LOT 1099919."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1022305 BD BBL¿ HEKTOEN ENTERIC AGAR CULTURE MEDIA, SELECTIVE AND DIFFERENTIAL JSI BECTON, DICKINSON & CO. (SPARKS) 221365 1099191 10382902213656

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown