BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL; COLUMBIA AGAR WITH 5% SHEEP BLOOD

    MDR report key: 11404991 · Received March 3, 2021

    Report

    Report Number
    1119779-2021-00418
    Event Type
    Malfunction
    Date Received
    March 3, 2021
    Date of Event
    February 6, 2021
    Report Date
    September 9, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    KZI
    UDI-DI
    10382902211652
    PMA / PMN Number
    PREAMENDMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: DURING MANUFACTURING OF MATERIAL 221165, 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 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. 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. BATCH NUMBER 031981 WAS PROVIDED FOR INVESTIGATION. MANUFACTURING RECORDS WERE REVIEWED AND NO BATCH NUMBER 031981 WAS MADE OF MATERIAL 221165. BATCH NUMBER 031981 IS INVALID AND CANNOT BE FURTHER INVESTIGATED. ONE PHOTO WAS RECEIVED FOR INVESTIGATION. THE PHOTO SHOWS THE SURFACE OF A MEDIUM RED AGAR PLATE. THE COMPLAINT DESCRIBES FUNGUS BUT NO FUNGAL GROWTH IS SEEN IN THE PHOTO. ALSO, NO PLATE PRINT OR PRODUCT LABELS ARE VISIBLE IN THE PHOTO TO IDENTIFY THE PLATE. NO RETURN SAMPLES WERE RECEIVED FOR INVESTIGATION. RETENTION SAMPLES CANNOT BE EVALUATED WITHOUT A SPECIFIC BATCH NUMBER. TRENDING WAS DONE ON THE APPROPRIATE DATA BASES FOR MATERIAL 221165 AND NO HISTORY COULD BE FOUND FOR CONTAMINATION ISSUES FROM QC TESTING IN THE LAST 12 MONTHS. THE COMPLAINT HISTORY WAS REVIEWED FOR MATERIAL 221165 AND THERE ARE NO TRENDS FOR CONTAMINATION IN ANY BATCH OVER THE LAST 12 MONTHS. THIS COMPLAINT CANNOT BE CONFIRMED. BD WILL CONTINUE TO TREND COMPLAINTS FOR CONTAMINATION. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USE WITH 80 BD BBL¿; COLUMBIA AGAR WITH 5% SHEEP BLOOD FUNGUS WAS DISCOVERED IN PLATES.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE LOT #: 031981 WAS REPORTED, HOWEVER, THIS IS NOT A LOT# MANUFACTURED FOR THIS PRODUCT. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO USE WITH 80 BD BBL¿; COLUMBIA AGAR WITH 5% SHEEP BLOOD FUNGUS WAS DISCOVERED IN PLATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301208 BD BBL; COLUMBIA AGAR WITH 5% SHEEP BLOOD CULTURE MEDIA, ENRICHED KZI BECTON, DICKINSON & CO. (SPARKS) 221165 031981 10382902211652

    Patients

    Seq Age Sex Outcome Treatment
    1