BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATE COLUMBIA AGAR 5% SB 20 EA

    MDR report key: 12394311 · Received August 31, 2021

    Report

    Report Number
    2243072-2021-02202
    Event Type
    Malfunction
    Date Received
    August 31, 2021
    Date of Event
    August 3, 2021
    Report Date
    August 20, 2021
    Manufacturer
    BECTON DICKINSON
    Product Code
    KZI
    PMA / PMN Number
    PREAMENDMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    OEM MANUFACTURE: THE MANUFACTURING LOCATION FOR THIS PRODUCT IS (B)(4). THIS SITE IS AN OEM MANUFACTURING SITE. (B)(4). 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¿ COLUMBIA AGAR WITH 5% SHEEP BLOOD CATALOG NUMBER 221165 WHICH IS A PREAMENDMENT DEVICE. INVESTIGATION SUMMARY: THE COMPLAINT WAS CONFIRMED AS THE REPORTED DEFECT ON A PICTURE. IT SEEMED LIKE CONTAMINATION FROM PHOTO, BUT WE DID NOT RECEIVE RETURNED SAMPLE. A CUSTOMER REPORT IS NOT REQUIRED, AND IT IS KNOWN DEFECT AND THE TREND HAS NOT SHOWN A REMARKABLE RISE, SO WE DECIDED THAT FURTHER INVESTIGATIONS IS NOT NECESSARY. WE WILL CONTINUE TO MONITOR THE TREND THIS ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING PLATE COLUMBIA AGAR 5% SB 20 EA CONTAMINATION WAS OBSERVED BY THE LABORATORY PERSONNEL. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THIS IS A REPORT ABOUT CONTAMINATION OF THE MEDIA."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1287016 PLATE COLUMBIA AGAR 5% SB 20 EA CULTURE MEDIA, ENRICHED KZI BECTON DICKINSON 1112643

    Patients

    Seq Age Sex Outcome Treatment
    1