BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 14639707 · Received June 8, 2022

    Report

    Report Number
    9680577-2022-00072
    Event Type
    Malfunction
    Date Received
    June 8, 2022
    Date of Event
    May 24, 2022
    Report Date
    June 9, 2022
    Manufacturer
    BECTON DICKINSON GMBH
    Product Code
    JSG
    PMA / PMN Number
    PREAMENDMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 2039481, MEDICAL DEVICE EXPIRATION DATE: 16-MAY-200, DEVICE MANUFACTURE DATE: 2022-02-08. MEDICAL DEVICE LOT #: 2063352, MEDICAL DEVICE EXPIRATION DATE: 2022-06-16, DEVICE MANUFACTURE DATE: 2022-03-04. INITIAL REPORTER PHONE#: (B)(6). 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

    ADDITIONAL INFORMATION RECEIVED: B.5. DESCRIBE EVENT OR PROBLEM: WE HAVE ALSO CARRIED OUT TESTS ON WHETHER THE PLATES CAN BE STORED AT ROOM TEMPERATURE FOR 24 HOURS ¿ 6 DAYS, AND IN THESE TESTS THE LOW VALUES FOR THE TWO GERMS P. AERUGINOSA AND E. COLI HAVE ALSO BEEN CONFIRMED. BOTH ON 03.05., 04.05. AND 17.05. WE HAD NO PROBLEMS WITH OTHER CULTURE MEDIA IN THE RECOVERY OF THE TWO GERMS, SO IT CAN NOT BE DUE TO OUR BACTERIAL SUSPENSION. MAYBE YOU CAN TALK INTERNALLY ABOUT WHAT THE PROBLEM MIGHT BE? I HAVE SEEN FROM THE CERTIFICATE THAT YOU TEST WITH OTHER TEST GERMS, OR USE A DIFFERENT ATCC STRAIN FOR E. COLI. ADDITIONAL INFORMATION WAS RECEIVED THAT MADE THIS EVENT NOT REPORTABLE. ATCC STRAIN IS A QC ONLY TEST. THE MDR IS TO BE CONSIDERED CANCELED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT INSUFFICIENT GROWTH FOR BD BBL¿ TRYPTICASE¿ SOY AGAR WITH 5% SHEEP BLOOD (TSA II) WAS IDENTIFIED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "INSUFFICIENT RECOVERY RATE FOR STANDARD MICRO ORGANISMS (ASTM; E.COLI, B. SUBTILIS; S. AUREUS AND P. AERUGINOSA)"

    Description of Event or Problem · 0

    IT WAS REPORTED THAT INSUFFICIENT GROWTH FOR BD BBL¿ TRYPTICASE¿ SOY AGAR WITH 5% SHEEP BLOOD (TSA II) WAS IDENTIFIED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "INSUFFICIENT RECOVERY RATE FOR STANDARD MICRO ORGANISMS (ASTM; E.COLI, B. SUBTILIS; S. AUREUS AND P. AERUGINOSA)". ADDITIONAL INFORMATION: WE HAVE ALSO CARRIED OUT TESTS ON WHETHER THE PLATES CAN BE STORED AT ROOM TEMPERATURE FOR 24 HOURS ¿ 6 DAYS, AND IN THESE TESTS THE LOW VALUES FOR THE TWO GERMS P. AERUGINOSA AND E. COLI HAVE ALSO BEEN CONFIRMED. BOTH ON 03.05., 04.05. AND 17.05. WE HAD NO PROBLEMS WITH OTHER CULTURE MEDIA IN THE RECOVERY OF THE TWO GERMS, SO IT CAN NOT BE DUE TO OUR BACTERIAL SUSPENSION. MAYBE YOU CAN TALK INTERNALLY ABOUT WHAT THE PROBLEM MIGHT BE? I HAVE SEEN FROM THE CERTIFICATE THAT YOU TEST WITH OTHER TEST GERMS, OR USE A DIFFERENT ATCC STRAIN FOR E. COLI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2055710 BD BBL¿ TRYPTICASE¿ SOY AGAR WITH 5% SHEEP BLOOD (TSA II) CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL JSG BECTON DICKINSON GMBH SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown