BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATE TRYPTICASE SOY AGAR 5% SB 100 EA

    MDR report key: 15677124 · Received October 26, 2022

    Report

    Report Number
    1119779-2022-01333
    Event Type
    Malfunction
    Date Received
    October 26, 2022
    Date of Event
    October 18, 2022
    Report Date
    October 31, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JSG
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY: COMPLAINT HISTORY WAS REVIEWED, AND NO OTHER COMPLAINT HAS BEEN TAKEN ON THIS LOT. AT THIS TIME. DID NOT INDICATE ANY DISCREPANCIES. ALL RELEASE TESTING WAS SATISFACTORY AND NO DEVIATIONS WERE OBSERVED. IT INCLUDES BIOBURDEN TESTING. A VISUAL INSPECTION WAS PERFORMED ON 20 RETENTION SAMPLES OF THIS LOT. AS A RESULT,NO CONTAMINATION WAS OBSERVED. THE ROOT CAUSE FOR THIS COULD NOT BE DETERMINED WE WILL CONTINUE TO MONITOR THIS LOT.

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING PLATE TRYPTICASE SOY AGAR 5% SB 100 EA CONTAMINATION OCCURRED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "ACCORDING TO THE CUSTOMER'S REPORT, BACILLUS LICHENIFORMIS WAS DETECTED IN ONE PLATE OUT OF 1000 (100 PLATES X 10 CARTONS) BEFORE USAGE.".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING PLATE TRYPTICASE SOY AGAR 5% SB 100 EA CONTAMINATION OCCURRED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "ACCORDING TO THE CUSTOMER'S REPORT, BACILLUS LICHENIFORMIS WAS DETECTED IN ONE PLATE OUT OF 1000 (100 PLATES X 10 CARTONS) BEFORE USAGE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2802917 PLATE TRYPTICASE SOY AGAR 5% SB 100 EA CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL JSG BECTON, DICKINSON & CO. (SPARKS) 2228492

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown