BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATE MUELLER HINTON II AGAR 150MM 24 EA)

    MDR report key: 17134707 · Received June 15, 2023

    Report

    Report Number
    1119779-2023-00649
    Event Type
    Malfunction
    Date Received
    June 15, 2023
    Date of Event
    May 18, 2023
    Report Date
    June 30, 2023
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    JTZ
    PMA / PMN Number
    PREAMENDMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6. INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES, BUT 1PHOTO WAS PROVIDED FOR INVESTIGATION. THE PHOTO WAS REVIEWED AND BIOLOGICAL CONTAMINATION COULD NOT BE CONFIRMED AS THE PHOTO WAS THE UNDERSIDE OF THE PLATED MEDIA. FM WAS OBSERVED, BUT WITHOUT A RETURN SAMPLE, FURTHER IDENTIFICATION COULD NOT BE CONDUCTED. ADDITIONALLY, RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED FOR FOREIGN MATTER AND NONE WERE OBSERVED. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOT, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THERE WERE NO RELATED QUALITY ISSUES DURING MANUFACTURING OF THE PRODUCT. THIS COMPLAINT HAS BEEN CONFIRMED FOR FOREIGN MATTER BASED ON THE PHOTO PROVIDED. 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.

    Additional Manufacturer Narrative · 0

    D.3 COMMON DEVICE NAME: CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST, MUELLER HINTON AGAR/BROTH G5. THERE IS NO 510(K) FOR THIS DEVICE AS IT IS MANUFACTURED OUTSIDE THE US AND NOT SOLD IN THE US, BUT IT IS CONSIDERED TO BE SUBSTANTIALLY SIMILAR TO THE LEGALLY U.S. MARKETED DEVICE PLATE MUELLER HINTON II AGAR 150MM 24 EA) , CATALOG NUMBER 251800 WITH 510K #221177. H.3. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE PLATE MUELLER HINTON II AGAR 150MM 24 EA) THAT THERE WAS BIOLOGICAL CONTAMINATION THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ACCORDING TO THE CUSTOMER'S REPORT, FM WAS FOUND IN THE MEDIA BEFORE USAGE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE PLATE MUELLER HINTON II AGAR 150MM 24 EA) THAT THERE WAS BIOLOGICAL CONTAMINATION THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ACCORDING TO THE CUSTOMER'S REPORT, FM WAS FOUND IN THE MEDIA BEFORE USAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1956159 PLATE MUELLER HINTON II AGAR 150MM 24 EA) SEE H.10 JTZ BECTON DICKINSON & CO. (SPARKS) 3023324

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown