BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ CDC ANAEROBE 5% SHEEP BLOOD AGAR

    MDR report key: 16410520 · Received February 21, 2023

    Report

    Report Number
    1119779-2023-00163
    Event Type
    Malfunction
    Date Received
    February 21, 2023
    Date of Event
    February 13, 2023
    Report Date
    May 24, 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
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 2341496 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. THE COMPLAINT HISTORY WAS REVIEWED, AND NO OTHER COMPLAINTS HAVE BEEN TAKEN ON BATCH 2341496. RETENTION SAMPLES FROM BATCH 2341496 WERE NOT AVAILABLE FOR INSPECTION. TWO PHOTOS WERE RECEIVED FOR INVESTIGATION. ONE PHOTO SHOWS A SLEEVE FROM AN OPENED 100PACK CARTON WITH NO SLEEVE LABEL VISIBLE. THE OTHER PHOTO SHOWS A SLEEVE FROM BATCH 2341496 IN A 100PACK CARTON NEXT TO A SLEEVE WITHOUT A VISIBLE SLEEVE LABEL. 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. THIS COMPLAINT CAN BE CONFIRMED BY THE PHOTOS PROVIDED. COMPLAINT TRENDING DATA HAS NOT IDENTIFIED A COMPLAINT TREND FOR SLEEVE LABELING ISSUES. COMPLAINT TRENDING IS PERFORMED BY MONTHLY STATISTICAL ANALYSIS OF COMPLAINT DATA AND TRENDS ARE IDENTIFIED BY DEFECT PER BD PROCEDURES. THIS ALLOWS BD TO IDENTIFY COMPREHENSIVELY POSSIBLE ISSUES OF THE MANUFACTURING PROCESS. BD ACKNOWLEDGES THE COMPLAINTS FROM LIFENET HEALTH FOR MISSING SLEEVE LABELS. NO OTHER COMPLAINTS FOR MISSING SLEEVE LABELS HAVE BEEN TAKEN FROM ANY OTHER CUSTOMERS FOR THE BATCHES FROM LIFENET HEALTH'S COMPLAINTS. NO COMPLAINT TREND FOR LABELING DEFECTS HAS BEEN IDENTIFIED. BD WILL CONTINUE TO TREND COMPLAINTS FOR LABELING DEFECTS.

    Additional Manufacturer Narrative · 0

    COMMON DEVICE NAME: CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL. (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE BD BBL¿ CDC ANAEROBE 5% SHEEP BLOOD AGAR THAT THERE WAS A LABEL ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTS 2 CT WERE MISSING LABELS FOR PRODUCT 221734 LOT 2341496 - PLATE CDC ANAEROBE 5% SB 100 EA.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE BD BBL¿ CDC ANAEROBE 5% SHEEP BLOOD AGAR THAT THERE WAS A LABEL ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTS 2 CT WERE MISSING LABELS FOR PRODUCT 221734, LOT 2341496 - PLATE CDC ANAEROBE 5% SB 100 EA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1667236 BD BBL¿ CDC ANAEROBE 5% SHEEP BLOOD AGAR SEE H.10 JSG BECTON, DICKINSON & CO. (SPARKS) 221734 2341496 10382902217340

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown