BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 15659988 · Received October 24, 2022

    Report

    Report Number
    1119779-2022-01326
    Event Type
    Malfunction
    Date Received
    October 24, 2022
    Date of Event
    October 6, 2022
    Report Date
    October 31, 2022
    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

    IN THIS MDR, BD DS HEADQUARTERS IN (B)(4) HAS BEEN LISTED AS (B)(4) IS AN OEM MANUFACTURING SITE. 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

    H.6 INVESTIGATION SUMMARY: 251239 #2193402 WE COULD CONFIRM THIS ISSUE AS A REPORT FROM RETURNED SAMPLE. THE ISSUE WAS CONTAMINATION OF CLADOSPORIUM SP. COMPLAINT HISTORY WAS REVIEWED, AND NO OTHER COMPLAINT HAS BEEN TAKEN ON THIS LOT. AT THIS TIME. DID NOT INDICATE ANY DISCREPANCIES. ALL RELEASE TESTING WAS SATISFACTORY AND NO DEVIATIONS WERE OBSERVED. IT INCLUDES BIOBURDEN TESTING. A VISUAL INSPECTION WAS PERFORMED ON 20 RETENTION SAMPLES OF THIS LOT. AS A RESULT,NO CONTAMINATION WAS OBSERVED. THE ROOT CAUSE FOR THIS COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD BBL¿ TRYPTICASE¿ SOY AGAR WITH 5% SHEEP BLOOD (TSA II) WAS FOUND TO HAVE BACTERIAL GROWTH IN THE MEDIA. THIS HAD AN OCCURRENCE OF 20. NO PATIENT IMPACT WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ACCORDING TO THE CUSTOMER'S REPORT, BACTERIAL GROWTH WAS FOUND IN THE MEDIA.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD BBL¿ TRYPTICASE¿ SOY AGAR WITH 5% SHEEP BLOOD (TSA II) WAS FOUND TO HAVE BACTERIAL GROWTH IN THE MEDIA. THIS HAD AN OCCURRENCE OF 20. NO PATIENT IMPACT WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ACCORDING TO THE CUSTOMER'S REPORT, BACTERIAL GROWTH WAS FOUND IN THE MEDIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2028830 BD BBL¿ TRYPTICASE¿ SOY AGAR WITH 5% SHEEP BLOOD (TSA II) CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL JSG BECTON, DICKINSON & CO. (SPARKS) 2193402

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown