BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ CDC ANAEROBE 5% SHEEP BLOOD AGAR

    MDR report key: 16970072 · Received May 19, 2023

    Report

    Report Number
    1119779-2023-00580
    Event Type
    Malfunction
    Date Received
    May 19, 2023
    Date of Event
    April 20, 2023
    Report Date
    June 2, 2023
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JSG
    UDI-DI
    10382902217340
    PMA / PMN Number
    K803025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER ADDR 1: (B)(6). 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

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH ADDITIONAL INFORMATION: D.10 DEVICE AVAILABLE FOR EVAL? YES, D.10 RETURNED TO MANUFACTURER ON: 01-JUN-2023. H.6. INVESTIGATION SUMMARY: DURING MANUFACTURING OF MATERIAL 221734, 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 3026515 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. RETENTION SAMPLES FROM BATCH 3026515 WERE NOT AVAILABLE FOR INSPECTION. ONE PHOTO WAS RECEIVED FOR INVESTIGATION. THE PHOTO SHOWS TEN SLEEVES OF MEDIUM RED AGAR PLATES WITH NO SLEEVE LABELS VISIBLE. NO PLATE PRINTS OR PRODUCT LABELS WERE VISIBLE IN THE PHOTO FOR BATCH VERIFICATION. WITHOUT BATCH VERIFICATION, THIS COMPLAINT CANNOT BE CONFIRMED BY THE PHOTO. NO RETURN SAMPLES WERE RECEIVED FOR INVESTIGATION. THE MANUFACTURING PROCESS WAS REVIEWED FOR THIS INVESTIGATION AND THERE HAVE BEEN NO CHANGES TO THE SLEEVE LABEL OR LABELING PROCESS FOR THIS PRODUCT. REVIEW OF THE MANUFACTURING RECORDS FOR THIS BATCH DID NOT FIND ANY DEVIATIONS OR INTERVENTIONS DURING THE MANUFACTURING PROCESS TO INDICATE MECHANICAL FAILURES OF THE LABELING PROCESS. THIS PRODUCT IS PACKAGED INTO SLEEVES AND LABELED VIA AN AUTOMATED PROCESS. DUE TO THE MECHANICAL NATURE OF THE LABELING PROCESS, BD CANNOT GUARANTEE THAT THERE WILL BE NO MISSING SLEEVE LABELS IN ANY BATCH OF THIS PRODUCT. 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. COMPLAINT TRENDING DATA HAS NOT IDENTIFIED A COMPLAINT TREND FOR SLEEVE LABELING ISSUES. THIS COMPLAINT CANNOT BE CONFIRMED. BD WILL CONTINUE TO TREND COMPLAINTS FOR LABELING DEFECTS. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD BBL¿ CDC ANAEROBE 5% SHEEP BLOOD AGAR THAT THERE WAS MISSING LABELS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER IS REPORTING 9CT WAS MISSING LABELS FOR ITEM 221734.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD BBL¿ CDC ANAEROBE 5% SHEEP BLOOD AGAR THAT THERE WAS MISSING LABELS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER IS REPORTING 9CT WAS MISSING LABELS FOR ITEM 221734.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    510406 BD BBL¿ CDC ANAEROBE 5% SHEEP BLOOD AGAR CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL JSG BECTON, DICKINSON & CO. (SPARKS) 221734 3026515 10382902217340

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown