BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ SALMONELLA SHIGELLA AGAR PLATE 20PK

    MDR report key: 16499208 · Received March 7, 2023

    Report

    Report Number
    1119779-2023-00238
    Event Type
    Malfunction
    Date Received
    March 7, 2023
    Date of Event
    February 22, 2023
    Report Date
    June 12, 2024
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JSI
    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

    INVESTIGATION SUMMARY MATERIAL #: [251181]LOT/BATCH #: #2325441 BD RECEIVED PHOTOS FOR EVALUATION. BD WAS ABLE TO DETERMINE THE ISSUE WAS PRECIPITATION. THIS COMPLAINT IS ABLE TO BE CONFIRMED. THE COMPLAINT HISTORY HAS BEEN REVIEWED AND NO TREND WAS IDENTIFIED. THE BATCH HISTORY REVIEW DID NOT INDICATE ANY DISCREPANCIES. ALL RELEASE TESTING WAS SATISFACTORY, AND NO DEVIATIONS WERE OBSERVED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    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 BD BBL¿ SALMONELLA SHIGELLA AGAR PLATE 20PK MOLD WAS FOUND IN THE MEDIA. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ACCORDING TO THE CUSTOMER'S REPORT, BACTERIAL RESEMBLING MOLD WAS FOUND ON THE MEDIA.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD BBL¿ SALMONELLA SHIGELLA AGAR PLATE 20PK MOLD WAS FOUND IN THE MEDIA. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ACCORDING TO THE CUSTOMER'S REPORT, BACTERIAL RESEMBLING MOLD WAS FOUND ON THE MEDIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86504 BD BBL¿ SALMONELLA SHIGELLA AGAR PLATE 20PK CULTURE MEDIA, SELECTIVE AND DIFFERENTIAL JSI BECTON, DICKINSON & CO. (SPARKS) 2325441

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown