BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATE BD CHROMAGAR O-157 20 EA

    MDR report key: 12305305 · Received August 10, 2021

    Report

    Report Number
    2243072-2021-02046
    Event Type
    Malfunction
    Date Received
    August 10, 2021
    Date of Event
    July 13, 2021
    Report Date
    August 4, 2021
    Manufacturer
    BECTON DICKINSON
    Product Code
    JSI
    PMA / PMN Number
    K070691
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: THE DEFECT WAS NOT CONFIRMED BECAUSE THERE IS NO PICTURE AND 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. 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¿ CHROMAGAR¿ O157 CATALOG NUMBER 214984 WHICH HAS 510K NUMBER K070691.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING 20 PLATE BD CHROMAGAR O-157 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: "ACCORDING TO THE CUSTOMER¿S INFORMATION, DOTS LIKE MOLD WERE FOUND ON THE MEDIA."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1202320 PLATE BD CHROMAGAR O-157 20 EA CULTURE MEDIA, SELECTIVE AND DIFFERENTIAL JSI BECTON DICKINSON 1104959

    Patients

    Seq Age Sex Outcome Treatment
    1