BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ SALMONELLA SHIGELLA AGAR

    MDR report key: 16549586 · Received March 15, 2023

    Report

    Report Number
    1119779-2023-00286
    Event Type
    Malfunction
    Date Received
    March 15, 2023
    Date of Event
    March 7, 2023
    Report Date
    March 12, 2023
    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

    COMMON DEVICE NAME: CULTURE MEDIA, SELECTIVE AND DIFFERENTIAL. DEVICE EVALUATED BY MFR: A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. INVESTIGATION SUMMARY: MATERIAL #: 251181. LOT/BATCH #: 2325441. BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR EVALUATION. THIS LOT WAS ALREADY EXPIRED AND RETENTION WAS ALREADY DISCARDED. BASED ON A REVIEW OF THE BATCH HISTORY RECORD FOR THE INCIDENT LOT, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THERE WERE NO RELATED QUALITY ISSUES DURING MANUFACTURING OF THE PRODUCT. THIS COMPLAINT IS NOT CONFIRMED FOR THE INDICATED FAILURE MODE CONTAMINATION. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE BD BBL¿ SALMONELLA SHIGELLA AGAR THAT THERE WAS CONTAMINATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ACCORDING TO THE CUSTOMER'S REPORT, BACTERIAL GROWTH WAS FOUND IN THE MEDIA BEFORE USAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    835366 BD BBL¿ SALMONELLA SHIGELLA AGAR SEE H.10 JSI BECTON, DICKINSON & CO. (SPARKS) 2325441

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown