BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATE CDC ANAEROBE 5% SB 20 EA

    MDR report key: 12081228 · Received June 28, 2021

    Report

    Report Number
    2243072-2021-01767
    Event Type
    Malfunction
    Date Received
    June 28, 2021
    Date of Event
    May 31, 2021
    Report Date
    June 21, 2021
    Manufacturer
    BECTON DICKINSON
    Product Code
    JSG
    PMA / PMN Number
    K803025
    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. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. 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" CDC ANAEROBE 5% SHEEP BLOOD AGAR CATALOG NUMBER 4221733 WHICH HAS 510K NUMBER K803025. INVESTIGATION SUMMARY: THE COMPLAINT WAS CONFIRMED AS THE REPORTED DEFECT ON A RETURNED SAMPLE ]. THE ISSUE WAS CONTAMINATION. NO ISSUE IN DHR. ROOT CAUSE WAS UNDETERMINED. NO ISSUE IN RETENTION SAMPLE. NO TREND WE WILL CONTINUE TO MONITOR THE TREND THIS ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING 6 KIT FLU A+B 30 TEST PHYSICIAN VERITOR 2 FALSE POSITIVE RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. A CEPHEID TEST WAS USED TO CONFIRM THE RESULTS AS FALSE POSITIVES. 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 MOLDS GROWING ON THE MEDIA. ACCORDING TO THE CUSTOMER'S REPORT, MOLDS WERE GROWING ON THE MEDIA, "

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    977218 PLATE CDC ANAEROBE 5% SB 20 EA CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL JSG BECTON DICKINSON 1083359

    Patients

    Seq Age Sex Outcome Treatment
    1