BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 17507397 · Received August 11, 2023

    Report

    Report Number
    1119779-2023-00871
    Event Type
    Malfunction
    Date Received
    August 11, 2023
    Date of Event
    July 26, 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

    H.6. INVESTIGATION SUMMARY: 251239 #3143197 . WE COULD CONFIRM THIS ISSUE AS A REPORT FROM RETURNED SAMPLE AND PHOTO. THIS ISSUE WAS CONTAMINATION. NO ISSUE IN RETENTION SAMPLE. NO ISSUE IN DHR. NO TREND. ROOT CAUSE WAS UNDETERMINED. WE WILL CONTINUE TO MONITOR THIS LOT. THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED AND/OR ADDITIONAL INFORMATION. D9: DEVICE AVAILABLE FOR EVALUATION: YES. D9: RETURNED TO MANUFACTURER ON: 12-OCT-2023 H3 OTHER TEXT : SEE H.10.

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USE WITH BD BBL¿ TRYPTICASE¿ SOY AGAR WITH 5% SHEEP BLOOD (TSA II) "BLACK" FOREIGN MATTER WAS DISCOVERED IN THE MEDIA. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: ACCORDING TO THE CUSTOMER'S REPORT, BLACK SPOTS WERE FOUND IN THE MEDIA AND THE AFFECTED MEDIA WAS THUS NOT USED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USE WITH BD BBL¿ TRYPTICASE¿ SOY AGAR WITH 5% SHEEP BLOOD (TSA II) "BLACK" FOREIGN MATTER WAS DISCOVERED IN THE MEDIA. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: ACCORDING TO THE CUSTOMER'S REPORT, BLACK SPOTS WERE FOUND IN THE MEDIA AND THE AFFECTED MEDIA WAS THUS NOT USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1072749 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