BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ COLUMBIA AGAR WITH 5% SHEEP BLOOD

    MDR report key: 15529375 · Received October 3, 2022

    Report

    Report Number
    1119779-2022-01264
    Event Type
    Malfunction
    Date Received
    October 3, 2022
    Date of Event
    September 20, 2022
    Report Date
    November 23, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    KZI
    UDI-DI
    10382902212635
    PMA / PMN Number
    PREAMENDMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 221263, 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 2132218 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 NO OTHER COMPLAINTS HAVE BEEN TAKEN ON BATCH 2132218. RETENTION SAMPLES FROM BATCH 2132218 WERE NOT AVAILABLE FOR INSPECTION. TEN PLATES FROM BATCH 2132218 WERE RETURNED AS ONE UNOPENED SLEEVE SHIPPED IN A BOX WITH ICE PACKS AND BUBBLE WRAP. PLATES WERE INSPECTED AND 0/10 PLATES HAD MICROBIAL GROWTH (TIME STAMPS 0053 AND 0054). FOR INVESTIGATION OF THIS COMPLAINT, THE INSPECTED PLATES WERE THEN INCUBATED AT 20 TO 25 DEGREES C (5 PLATES) AND 33 TO 37 DEGREES C (5 PLATES). AT THREE DAYS INCUBATION, NO MICROBIAL GROWTH WAS OBSERVED IN 10/10 INCUBATED RETURN PLATES. NO PHOTOS WERE RECEIVED FOR INVESTIGATION. THIS COMPLAINT CANNOT BE CONFIRMED FOR CONTAMINATION. NO COMPLAINT TRENDS FOR CONTAMINATION HAVE BEEN IDENTIFIED FOR THIS PRODUCT; NO ACTIONS ARE INDICATED AT THIS TIME. ADDITIONALLY, MATERIAL 221263 DOES NOT HAVE A STERILE CLAIM. BD WILL CONTINUE TO TREND COMPLAINTS FOR CONTAMINATION. RISK MANAGEMENT FILE REVIEW ASSESSED THE POTENTIAL RISK FOR THE DEFECT AS SEVERITY S1 PER BALTRMPPMGENPURAPH, REV 02, ID 6.13.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THEY HAD BIOLOGICAL CONTAMINATION ON BD BBL¿ COLUMBIA AGAR WITH 5% SHEEP BLOOD. THERE WAS ONE OCCURRENCE IN THIS EVENT WITH NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE CUSOTMER: (B)(6) CONTAMINATION. LOT EXPIRED ON 2022/09/07.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THEY HAD BIOLOGICAL CONTAMINATION ON BD BBL¿ COLUMBIA AGAR WITH 5% SHEEP BLOOD. THERE WAS ONE OCCURRENCE IN THIS EVENT WITH NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE CUSTOMER: "COLUMBIA AGAR 221263_2132218 CONTAMINATION. LOT EXPIRED ON 2022/09/07."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2383304 BD BBL¿ COLUMBIA AGAR WITH 5% SHEEP BLOOD CULTURE MEDIA, ENRICHED KZI BECTON, DICKINSON & CO. (SPARKS) 221263 2132218 10382902212635

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown