BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 14282453 · Received May 4, 2022

    Report

    Report Number
    1119779-2022-00646
    Event Type
    Malfunction
    Date Received
    May 4, 2022
    Date of Event
    April 4, 2022
    Report Date
    May 20, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JSG
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BD RECEIVED A COMPLAINT FOR MATERIAL NUMBER 251239 BATCH 2032331. THE DHR FOR BATCH 2032331 WAS SATISFACTORY AT TIME OF RELEASE AND NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND INSPECTION. THE COMPLAINT HISTORY WAS REVIEWED, AND NO OTHER COMPLAINTS HAVE BEEN RECEIVED. RETENTION SAMPLES WERE PULLED AND NO CONTAMINATION WAS NOTED. NO RETURNS WERE RECEIVED, BUT A PHOTO WAS PROVIDED AND THIS COMPLAINT IS CONFIRMED FOR CONTAMINATION. BD WILL CONTINUE TO TREND COMPLAINTS FOR APPEARANCE AND CONTAMINATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD BBL¿ TRYPTICASE¿ SOY AGAR WITH 5% SHEEP BLOOD (TSA II) THE CUSTOMER . THIS EVENT OCCURRED 1 TIME(S). THERE IS NO INDICATION THAT FALSE RESULTS WERE REPORTED TO HEALTH CARE PRACTITIONERS. THERE IS NO INDICATION OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "ACCORDING TO THE CUSTOMER'S REPORT, BACTERIAL GROWTH WAS FOUND IN 3 PLATES. THE AGAR IN THESE PLATES WAS DARK (MUDDY) RED AND BACTERIAL GROWTH WAS FOUND IN THE CENTER IN A PLATE AND AT THE EDGES IN 2 PLATES."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD BBL¿ TRYPTICASE¿ SOY AGAR WITH 5% SHEEP BLOOD (TSA II) THE CUSTOMER . THIS EVENT OCCURRED 1 TIME(S). THERE IS NO INDICATION THAT FALSE RESULTS WERE REPORTED TO HEALTH CARE PRACTITIONERS. THERE IS NO INDICATION OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "ACCORDING TO THE CUSTOMER'S REPORT, BACTERIAL GROWTH WAS FOUND IN 3 PLATES. THE AGAR IN THESE PLATES WAS DARK (MUDDY) RED AND BACTERIAL GROWTH WAS FOUND IN THE CENTER IN A PLATE AND AT THE EDGES IN 2 PLATES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667035 BD BBL¿ TRYPTICASE¿ SOY AGAR WITH 5% SHEEP BLOOD (TSA II) CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL JSG BECTON, DICKINSON & CO. (SPARKS) 2032331

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown