BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ HEKTOEN ENTERIC AGAR

    MDR report key: 12166893 · Received July 14, 2021

    Report

    Report Number
    1119779-2021-01167
    Event Type
    Malfunction
    Date Received
    July 14, 2021
    Date of Event
    June 14, 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
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 2021-06-18. 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. TWENTY-SEVEN PLATES FROM BATCH 1099191 WERE RETURNED AS TWO OPENED SLEEVES (20 PLATES) RETAPED IN A ZIPLOCK BAG AND SEVEN LOOSE, PARAFILMED PLATES IN A IZIPLOCK BAG SHIPPED IN A BOX WITH BUBBLE WRAP (TIME STAMPS 1231 AND 1234). PLATES WERE INSPECTED AND SURFACE BACTERIAL GROWTH WAS OBSERVED IN 15/27 RETURNED PLATES. ONE PLATE WAS SUBMITTED TO THE ID LAB AND PSEUDOMONAS FLUORESCENS WAS IDENTIFIED. FIVE PHOTOS ALSO WERE RECEIVED FOR INVESTIGATION. ONE PHOTO SHOWS THE AGAR SURFACE OF A PLATE WITH BACTERIAL COLONIES GROWING. TWO PHOTOS EACH FEATURE A SLEEVE LABEL FROM BATCH 1099191 FOR BATCH VERIFICATION. ONE PHOTOS SHOWS THE BOTTOM OF A PLATE FROM BATCH 1099191 (TIME STAMP 1231) WITH MICROBIAL GROWTH. THE LAST PHOTO SHOWS THE BOTTOM OF A SLEEVE WITH MICROBIAL GROWTH VISIBLE IN THE BOTTOM PLATE. 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. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING 2 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 CONTAMINATED PLATES. "

    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 2 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 CONTAMINATED PLATES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1066665 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