BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ TRYPTICASE¿ SOY AGAR WITH 5% SHEEP BLOOD (TSA II)

    MDR report key: 17695014 · Received September 6, 2023

    Report

    Report Number
    1119779-2023-00971
    Event Type
    Malfunction
    Date Received
    September 6, 2023
    Date of Event
    August 10, 2023
    Report Date
    October 17, 2023
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    JSG
    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

    INVESTIGATION SUMMARY: 251239 #3143197 . WE COULD CONFIRM THIS ISSUE AS A REPORT FROM RETURNED SAMPLE, PHOTO. THIS ISSUE WAS CONTAMINATION. NO ISSUE IN RETENTION AND DHR. NO TREND. ROOT CAUSE WAS UNDETERMINED. WE WILL CONTINUE TO MONITOR THIS ISSUE.

    Additional Manufacturer Narrative · 0

    H.3. 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¿ TRYPTICASE¿ SOY AGAR WITH 5% SHEEP BLOOD (TSA II) CONTAMINATION OCCURRED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS IS A REPORT ABOUT CONTAMINATION OF THE MEDIA. ACCORDING TO THE CUSTOMER'S REPORT, BACTERIAL GROWTH WAS FOUND INSIDE THE MEDIA BEFORE USAGE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD BBL¿ TRYPTICASE¿ SOY AGAR WITH 5% SHEEP BLOOD (TSA II) CONTAMINATION OCCURRED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS IS A REPORT ABOUT CONTAMINATION OF THE MEDIA. ACCORDING TO THE CUSTOMER'S REPORT, BACTERIAL GROWTH WAS FOUND INSIDE THE MEDIA BEFORE USAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1007613 BD BBL¿ TRYPTICASE¿ SOY AGAR WITH 5% SHEEP BLOOD (TSA II) CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL JSG BECTON DICKINSON & CO. (SPARKS) 3143197

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown