BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ XLD AGAR

    MDR report key: 17379673 · Received July 24, 2023

    Report

    Report Number
    1119779-2023-00797
    Event Type
    Malfunction
    Date Received
    July 24, 2023
    Date of Event
    July 5, 2023
    Report Date
    July 20, 2023
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    JSJ
    PMA / PMN Number
    PREAMENDMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3: DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. H.6. INVESTIGATION SUMMARY: 252020 #3081104 WE COULDN'T CONFIRM CONTAMINATION FROM RETURNED SAMPLE. THE ISSUE WAS PRECIPITATION. NO CONTAMINATION WAS OBSERVED. NO ISSUE IN RETENTION AND DHR. NO TREND. WE WILL CONTINUE TO MONITOR THIS LOT. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USING BD BBL¿ XLD AGAR, BACTERIAL COLONIES WERE FOUND ON 8 PLATES. THERE WAS NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "ACCORDING TO THE CUSTOMER'S REPORT, SMALL BACTERIAL COLONIES WERE FOUND IN THE UNUSED MEDIA WHEN THE EXPIRATION DATE WAS CLOSE. THE MEDIA HAD BEEN STORED IN A REFRIGERATOR."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    598765 BD BBL¿ XLD AGAR CULTURE MEDIA, SELECTIVE AND NON-DIFFERENTIAL JSJ BECTON DICKINSON & CO. (SPARKS) 3081104

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown