BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATE MUELLER HINTON AGAR 5% SB 20 EA

    MDR report key: 17148463 · Received June 16, 2023

    Report

    Report Number
    1119779-2023-00676
    Event Type
    Malfunction
    Date Received
    June 16, 2023
    Date of Event
    May 31, 2023
    Report Date
    June 23, 2023
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JTZ
    PMA / PMN Number
    SEE H10
    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 SPARKS, MD HAS BEEN LISTED IN SECTIONS D.3. AND G.1. AS FUKUSHIMA IS AN OEM MANUFACTURING SITE. E1. INITIAL REPORTER PHONE NUMBER: UNKNOWN. INITIAL REPORTER FACILITY NAME: (B)(6) HOSPITAL FOUNDATION. G5. 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 BBL - MUELLER HINTON AGAR WITH 5% SHEEP BLOOD CATALOG NUMBER 221176 WHICH IS A PREAMENDMENT DEVICE. H3. 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

    H6. INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR INVESTIGATION. IT IS NOTED, THE LOT # EXPIRED IN FEBRUARY. 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 IS UNABLE TO BE CONFIRMED FOR BIOLOGICAL CONTAMINATION. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. BD MAKES NO CLAIMS ON EXPIRED PRODUCT. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BBL - MUELLER HINTON AGAR WITH 5% SHEEP BLOOD MEDIA WAS CONTAMINATED PRIOR TO USE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE: ACCORDING TO THE CUSTOMER'S REPORT, BACTERIAL GROWTH WAS FOUND IN THE UNUSED MEDIA.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BBL - MUELLER HINTON AGAR WITH 5% SHEEP BLOOD MEDIA WAS CONTAMINATED PRIOR TO USE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE: ACCORDING TO THE CUSTOMER'S REPORT, BACTERIAL GROWTH WAS FOUND IN THE UNUSED MEDIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    527735 PLATE MUELLER HINTON AGAR 5% SB 20 EA CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST, MUELLER HINTON AGAR/BROTH JTZ BECTON, DICKINSON & CO. (SPARKS) 2298419

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown