BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ COLUMBIA CNA AGAR WITH 5% SHEEP BLOOD

    MDR report key: 17130762 · Received June 14, 2023

    Report

    Report Number
    1119779-2023-00657
    Event Type
    Malfunction
    Date Received
    June 14, 2023
    Date of Event
    May 17, 2023
    Report Date
    September 12, 2023
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JSJ
    UDI-DI
    10382902213533
    PMA / PMN Number
    PREAMENDMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D4. MEDICAL DEVICE LOT #: UNKNOWN. D4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H4. DEVICE MANUFACTURE DATE: UNKNOWN. H.3. 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 221353, 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. TWO PHOTOS WERE RECEIVED FOR INVESTIGATION. ONE PHOTO SHOWS A SLEEVE WITH NO SLEEVE LABEL AND TWO SLEEVES WITH LABELS IN THE BACKGROUND. THE INFORMATION ON THE SLEEVE LABELS IN THE BACKGROUND CANNOT BE READ. THE OTHER PHOTO SHOWS A 100PACK CARTON OPENED FROM THE SIDE WITH A STACK OF 10 PLATES IN THE BOX WITH THE SLEEVE MATERIAL NEXT TO IT. NO PRODUCT LABELS ARE IN THE PHOTO. NO BATCH NUMBER OR RETURN SAMPLES WERE PROVIDED FOR INVESTIGATION OF THIS COMPLAINT. WITHOUT A BATCH NUMBER, FURTHER INVESTIGATION INTO THE DEFECTS CANNOT BE MADE. RETENTION SAMPLES CANNOT BE EVALUATED WITHOUT A SPECIFIC BATCH NUMBER. TRENDING WAS PERFORMED ON THE APPROPRIATE QUALITY DATABASES AND NO TRENDS FOR MISSING SLEEVE LABELS OR PACKAGING DEFECTS WERE FOUND IN THE LAST 12 MONTHS. THE COMPLAINT HISTORY WAS REVIEWED FOR MATERIAL 221353 AND THERE ARE NO TRENDS FOR MISSING SLEEVE LABEL OR PACKAGING DEFECTS IN ANY BATCH OVER THE LAST 12 MONTHS. BD WILL CONTINUE TO TREND COMPLAINTS FOR MISSING SLEEVES LABELS AND PACKAGING DEFECTS. THIS COMPLAINT CANNOT BE CONFIRMED. THIS PRODUCT IS PACKAGED INTO SLEEVES AND LABELED VIA AN AUTOMATED PROCESS. IF A FAILURE IN THE SLEEVE LABELING PROCESS OCCURS, EACH PLATE OF THIS PRODUCT IS LABELED SO THE MEDIA TYPE, BATCH NUMBER AND EXPIRATION DATE ARE READILY AVAILABLE. THE PACKAGING OF THE SLEEVES OF THIS PRODUCT INTO CARTONS ALSO IS AN AUTOMATED PROCESS. WHILE WHAT IS SHOWN IN THE PHOTO OF A STACK OF PLATES AND THE SLEEVE MATERIAL BEING SEPARATED IN THE CARTON COULD OCCUR DURING THE PACKAGING PROCESS, IT CANNOT BE INVESTIGATED WITHOUT A SPECIFIC BATCH NUMBER AFFECTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE BD BBL¿ COLUMBIA CNA AGAR WITH 5% SHEEP BLOOD THAT THERE WAS A MISSING LABEL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: QUANTITY RECEIVED AND QUANTITY AFFECTED: 1 CASE. CUSTOMER REPORTING OPENED PACK AND MISSING LABEL OF PRODUCT 221353.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE BD BBL¿ COLUMBIA CNA AGAR WITH 5% SHEEP BLOOD THAT THERE WAS A MISSING LABEL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: QUANTITY RECEIVED AND QUANTITY AFFECTED: 1 CASE CUSTOMER REPORTING OPENED PACK AND MISSING LABEL OF PRODUCT 221353.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1875323 BD BBL¿ COLUMBIA CNA AGAR WITH 5% SHEEP BLOOD CULTURE MEDIA, SELECTIVE AND NON-DIFFERENTIAL JSJ BECTON, DICKINSON & CO. (SPARKS) 221353 UNKNOWN 10382902213533

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown