BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ COLUMBIA AGAR WITH 5% SHEEP BLOOD

    MDR report key: 19416118 · Received May 29, 2024

    Report

    Report Number
    1119779-2024-00442
    Event Type
    Malfunction
    Date Received
    May 29, 2024
    Date of Event
    April 30, 2024
    Report Date
    January 9, 2025
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    KZI
    UDI-DI
    10382902212635
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3. 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

    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 REVIEW FOR BATCH: 4043235 WAS SATISFACTORY AND NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND INSPECTION. THE RELEASE TESTING THAT IS PERFORMED ON THIS PRODUCT DOES INCLUDE SLEEVE ATTRIBUTE TESTING PRIOR TO RELEASE TO ENSURE THAT THEY CONFORM TO TYPICAL LEVELS. ALL SLEEVE 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: 4043235. THERE WERE NO RETENTION SAMPLES AVAILABLE FOR INVESTIGATION OF THIS COMPLAINT. 1 VIDEO WAS AVAILABLE FOR THIS INVESTIGATION. THE VIDEO SHOWED WHAT APPEARS TO BE A SLEEVE OF BLOOD AGAR PLATES WITH NO SLEEVE LABEL. THE PLATE PRINTS ARE NOT VISIBLE HOWEVER A PACKING SLIP WAS PROVIDED THAT CONFIRMS THE RECEIPT OF 221263/4043235 PLATE COLUMBIA AGAR5% SB 100 EA. NO RETURNS OR RETAINS WERE AVAILABLE FOR THIS INVESTIGATION. THIS COMPLAINT CAN BE CONFIRMED. NO COMPLAINT TRENDS FOR THIS DEFECT HAVE BEEN IDENTIFIED FOR THIS PRODUCT; NO ACTIONS ARE INDICATED AT THIS TIME. BD WILL CONTINUE TO TREND COMPLAINTS FOR MISSING LABELS.

    Description of Event or Problem · 0

    IT WAS REPORTED PRIOR TO USING BD BBL¿ COLUMBIA AGAR WITH 5% SHEEP BLOOD THAT ONE (1) SLEEVE WAS MISSING A PRODUCT LABEL. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED PRIOR TO USING BD BBL¿ COLUMBIA AGAR WITH 5% SHEEP BLOOD THAT ONE (1) SLEEVE WAS MISSING A PRODUCT LABEL. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630207 BD BBL¿ COLUMBIA AGAR WITH 5% SHEEP BLOOD CULTURE MEDIA, ENRICHED KZI BECTON DICKINSON & CO. (SPARKS) 4043235 10382902212635

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown