BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 14270119 · Received May 3, 2022

    Report

    Report Number
    1119779-2022-00641
    Event Type
    Malfunction
    Date Received
    May 3, 2022
    Date of Event
    April 6, 2022
    Report Date
    May 2, 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 IN AS (B)(4) 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. INVESTIGATION SUMMARY: 251239, LOT#: 2024421. WE DID NOT CONFIRM THIS ISSUE AS A REPORT BECAUSE THERE IS NO PHOTO AND RETURN. NO TREND. NO ISSUE IN RETENTION. WE WILL CONTINUE TO MONITOR THIS ISSUE.

    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), 2 PLATES WERE CONTAMINATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS IS A REPORT ABOUT CONTAMINATION OF THE MEDIA. ACCORDING TO THE CUSTOMER'S REPORT, THE MEDIA WAS FOUND TO BE CONTAMINATED UPON UNPACKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1762768 BD BBL¿ TRYPTICASE¿ SOY AGAR WITH 5% SHEEP BLOOD (TSA II) CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL JSG BECTON, DICKINSON & CO. (SPARKS) 2024421

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown