BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATE MUELLER HINTON II AGAR 20 EA

    MDR report key: 14881977 · Received June 30, 2022

    Report

    Report Number
    1119779-2022-00953
    Event Type
    Malfunction
    Date Received
    June 30, 2022
    Date of Event
    June 15, 2022
    Report Date
    October 6, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JTZ
    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 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¿ MUELLER HINTON II AGAR CATALOG NUMBER 211438 WHICH IS A PREAMENDMENT DEVICE. 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

    H.6 INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR INVESTIGATION. THEREFORE, RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED AND NO ISSUES WERE OBSERVED RELATING TO CONTAMINATION. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOT, A DISH STUCK ISSUE WAS NOTED, HOWEVER IT IS UNCLEAR IF THIS WAS RELATED TO THE REPORTED DEFECT. NO TREND WAS IDENTIFIED. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PLATE MUELLER HINTON II AGAR 20 EA PLATES WERE CONTAMINATED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS IS A REPORT ABOUT CONTAMINATION OF THE MEDIA. ACCORDING TO THE CUSTOMER'S REPORT, BACTERIAL GROWTH WAS FOUND IN THE MUELLER HINTON MEDIA BEFORE USAGE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PLATE MUELLER HINTON II AGAR 20 EA PLATES WERE CONTAMINATED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS IS A REPORT ABOUT CONTAMINATION OF THE MEDIA. ACCORDING TO THE CUSTOMER'S REPORT, BACTERIAL GROWTH WAS FOUND IN THE MUELLER HINTON MEDIA BEFORE USAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2279579 PLATE MUELLER HINTON II AGAR 20 EA CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST, MUELLER HINTON AGAR/BROTH JTZ BECTON, DICKINSON & CO. (SPARKS) 2088793

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown