BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 15009116 · Received July 13, 2022

    Report

    Report Number
    1119779-2022-00990
    Event Type
    Malfunction
    Date Received
    July 13, 2022
    Date of Event
    June 21, 2022
    Report Date
    September 30, 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

    IN THIS MDR, BD DS HEADQUARTERS IN (B)(4) HAS BEEN LISTED AS FUKUSHIMA IS AN OEM MANUFACTURING SITE. THERE IS NO 510(K) FOR THIS DEVICE AS IT IS MANUFACTURED OUTSIDE THE US AND NOT SOLD IN THE US BUT IS CONSIDERED TO BE SUBSTANTIALLY SIMILAR TO THE LEGALLY U.S. MARKETED DEVICE BD BBL¿ TRYPTICASE¿ SOY AGAR WITH 5% SHEEP BLOOD (TSA II) CATALOG NUMBER 221239 WHICH IS A CLASS 1, PREAMENDMENT DEVICE. 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

    H.6 INVESTIGATION SUMMARY: MATERIAL #: 251239. LOT/BATCH #: 2082588. BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR INVESTIGATION. THEREFORE, RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED AND NO ISSUES WERE OBSERVED RELATING TO CONTAMINATION. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOT, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THERE WERE NO RELATED QUALITY ISSUES DURING MANUFACTURING OF THE PRODUCT. THIS COMPLAINT IS UNABLE TO BE CONFIRMED FOR CONTAMINATION. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USE, BD BBL¿ TRYPTICASE¿ SOY AGAR WITH 5% SHEEP BLOOD (TSA II) MEDIA WAS CONTAMINATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE: ACCORDING TO THE CUSTOMER'S REPORT, THE MEDIA WAS FOUND TO BE CONTAMINATED BEFORE USAGE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USE, BD BBL¿ TRYPTICASE¿ SOY AGAR WITH 5% SHEEP BLOOD (TSA II) MEDIA WAS CONTAMINATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE: ACCORDING TO THE CUSTOMER'S REPORT, THE MEDIA WAS FOUND TO BE CONTAMINATED BEFORE USAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1955104 BD BBL¿ TRYPTICASE¿ SOY AGAR WITH 5% SHEEP BLOOD (TSA II) CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL JSG BECTON, DICKINSON & CO. (SPARKS) 2082588

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown