BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATE CHOCOLATE II AGAR 100 EA

    MDR report key: 14523266 · Received May 27, 2022

    Report

    Report Number
    1119779-2022-00762
    Event Type
    Malfunction
    Date Received
    May 27, 2022
    Date of Event
    April 28, 2022
    Report Date
    May 23, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JSG
    PMA / PMN Number
    K760459
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER PHONE#: (B)(6). INVESTIGATION SUMMARY: MATERIAL #: 251267, LOT/BATCH #: 2060539. BD RECEIVED SAMPLES FOR INVESTIGATION. THE SAMPLES WERE EVALUATED AND CONTAMINATION WAS OBSERVED IN (B)(4) OF THE (B)(4) SAMPLES RETURNED. NO ISSUE WAS FOUND IN RETENTION SAMPLES. NO TREND. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOT, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THIS COMPLAINT HAS BEEN CONFIRMED FOR CONTAMINATION. 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. OEM MANUFACTURE: THE MANUFACTURING LOCATION FOR THIS PRODUCT IS (B)(4). THIS SITE IS AN OEM MANUFACTURING SITE. THEREFORE, (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¿ MUELLER HINTON CHOCOLATE AGAR CATALOG NUMBER 221802 WHICH HAS 510K NUMBER K760459.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING PLATE CHOCOLATE II AGAR 100 EA CONTAMINATION WAS OBSERVED BY THE CUSTOMER. THIS EVENT OCCURRED 300 TIMES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE MEDIA WAS FOUND TO BE CONTAMINATED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2768925 PLATE CHOCOLATE II AGAR 100 EA CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL JSG BECTON, DICKINSON & CO. (SPARKS) 2060539

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown