BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATE BI COL CNA SB & COL CNA SB 100 EA

    MDR report key: 11877705 · Received May 25, 2021

    Report

    Report Number
    1119779-2021-00885
    Event Type
    Malfunction
    Date Received
    May 25, 2021
    Date of Event
    April 28, 2021
    Report Date
    October 20, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JSI
    UDI-DI
    10382902998188
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: DURING MANUFACTURING OF MATERIAL 299818, 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 1063379 WAS SATISFACTORY AND NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND INSPECTION. THE RELEASE TESTING THAT IS PERFORMED ON THIS PRODUCT DOES INCLUDE PHYSICAL ATTRIBUTE TESTING. A SAMPLE OF PLATES ARE INCUBATED AT 25 DEGREES C AND AT 35 DEGREES C FOR APPROXIMATELY 72 HOURS. THEY ARE TESTED FOR PHYSICAL ATTRIBUTES PRIOR TO RELEASE TO ENSURE THAT THEY CONFORM TO PRODUCT SPECIFICATIONS. ALL PHYSICAL ATTRIBUTE TESTING PERFORMED ON THIS BATCH WAS SATISFACTORY PER BD INTERNAL PROCEDURES. THE COMPLAINT HISTORY WAS REVIEWED, AND NO OTHER COMPLAINTS HAVE BEEN TAKEN ON BATCH 1063379. RETENTION SAMPLES FROM BATCH 1063379 WERE NOT AVAILABLE FOR INSPECTION. SEVEN PHOTOS WERE RECEIVED FOR INVESTIGATION. --ONE PHOTO SHOWS THE SIDE OF A PLATE FROM BATCH 1063379 (TIME STAMP 0600) WITH A CRACKED LID. --ONE PHOTO SHOWS THE BOTTOM OF EIGHT PLATES FROM BATCH 1063379 (TIME STAMP 0600) THAT ARE BROKEN. --ONE PHOTO SHOWS THE SIDE OF A BI-PLATE WITH A CRACKED LID. --ONE PHOTO SHOWS AN OPENED PLATE WITH A BROKEN LID. --ONE PHOTO SHOWS THE BOTTOM OF A PLATE FROM BATCH 1063379 WITH MICROBIAL GROWTH IN ONE BI-PLATE HALF VISIBLE. --ONE PHOTO SHOWS THE BOTTOM OF A PLATE FROM BATCH 1063379 WITH WHAT APPEARS TO HAVE BUBBLES IN AGAR OF ONE BI-PLATE HALF. --ONE PHOTO SHOWS THE AGAR SURFACE OF A BI-PLATE WITH BUBBLES IN THE MEDIA OF ONE HALF. NO RETURN SAMPLES WERE RECEIVED FOR INVESTIGATION. THIS COMPLAINT HAS BEEN CONFIRMED. BASED ON THE LOW DEFECT RATE FOR THIS BATCH, NO ACTIONS ARE PLANNED AT THIS TIME. BD WILL CONTINUE TO TREND COMPLAINTS FOR THESE DEFECTS. H3 OTHER TEXT : SEE H10.

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 · 0

    IT WAS REPORTED THAT WHILE USING A PLATE BI COL CNA SB & COL CNA SB 100 EA MOLD 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: "DAMAGED MILDEW AGAR UNEVEN SURFACE. "

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING A PLATE BI COL CNA SB & COL CNA SB 100 EA MOLD 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: "DAMAGED¿MILDEW¿AGAR UNEVEN SURFACE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    774649 PLATE BI COL CNA SB & COL CNA SB 100 EA CULTURE MEDIA, SELECTIVE AND DIFFERENTIAL JSI BECTON, DICKINSON & CO. (SPARKS) 299818 1063379 10382902998188

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown