BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BACTO¿ AGAR

    MDR report key: 16108885 · Received January 5, 2023

    Report

    Report Number
    1119779-2023-00002
    Event Type
    Malfunction
    Date Received
    January 5, 2023
    Date of Event
    December 23, 2022
    Report Date
    January 9, 2023
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JSK
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER FACILITY NAME: (B)(4). DEVICE EVALUATED BY MFR: A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    AFTER FURTHER EVALUATION OF THE COMPLAINT, IT HAS BEEN DETERMINED THAT THE PREVIOUSLY SUBMITTED REPORT 1119779-2023-00002 WAS SENT IN ERROR. THERE WAS NO REPORT OF SERIOUS INJURY, MEDICAL INTERVENTION, OR REPORTABLE DEVICE MALFUNCTION. THEREFORE THIS IS NOT CONSIDERED TO BE A REPORTABLE MALFUNCTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD BACTO¿ AGAR HAD DIFFERENT DESCRIPTION ON LABEL. WHILE THE CATALOG NUMBER MATCH SOMETHING DIFFERENTLY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: RECEIVED 4 PACKAGES OF BACTO AGAR. MEANWHILE, THE NAME ON THE OUTER LABEL IS AGAR DIFCO.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD BACTO¿ AGAR HAD DIFFERENT DESCRIPTION ON LABEL. WHILE THE CATALOG NUMBER MATCH SOMETHING DIFFERENTLY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: RECEIVED 4 PACKAGES OF BACTO AGAR. MEANWHILE, THE NAME ON THE OUTER LABEL IS AGAR DIFCO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194739 BD BACTO¿ AGAR SUPPLEMENT, CULTURE MEDIA JSK BECTON, DICKINSON & CO. (SPARKS) UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown