BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ LEVINE EMB AGAR

    MDR report key: 13524523 · Received February 14, 2022

    Report

    Report Number
    1119779-2022-00236
    Event Type
    Malfunction
    Date Received
    February 14, 2022
    Date of Event
    January 21, 2022
    Report Date
    July 18, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JSI
    UDI-DI
    10382902212680
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    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

    H6: INVESTIGATION SUMMARY: DURING MANUFACTURING OF MATERIAL 221268, 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 1308080 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 1308080 FOR CONTAMINATION. RETENTION SAMPLES FROM BATCH 1308080 WERE NOT AVAILABLE FOR INVESTIGATION. THERE WAS ONE PHOTO AVAILABLE FOR REVIEW OF THIS COMPLAINT. THE PHOTO SHOWS A SINGLE PLATE OPEN WITH VISIBLE CONTAMINATION. THE PLATE PRINT WAS NOT READABLE IN THE PHOTO AND NO OTHER PRODUCT LABELS WERE VISIBLE FOR BATCH VERIFICATION. WITHOUT BATCH VERIFICATION, THE PHOTO CANNOT CONFIRM THE COMPLAINT. NO RETURN SAMPLES WERE RECEIVED FOR INVESTIGATION. THIS COMPLAINT CANNOT BE CONFIRMED. BD WILL CONTINUE TO TREND COMPLAINTS FOR CONTAMINATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD BBL¿ LEVINE EMB AGAR WAS CONTAMINATED. THERE WAS NO REPORT OF USER OR PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "POLLUTION".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD BBL¿ LEVINE EMB AGAR WAS CONTAMINATED. THERE WAS NO REPORT OF USER OR PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "POLLUTION".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1118681 BD BBL¿ LEVINE EMB AGAR CULTURE MEDIA, SELECTIVE AND DIFFERENTIAL JSI BECTON, DICKINSON & CO. (SPARKS) 221268 1308080 10382902212680

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown