BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATE MUELLER HINTON AGAR 5% SB 20 EA

    MDR report key: 12572743 · Received October 4, 2021

    Report

    Report Number
    2243072-2021-02444
    Event Type
    Malfunction
    Date Received
    October 4, 2021
    Date of Event
    September 7, 2021
    Report Date
    October 21, 2021
    Manufacturer
    BECTON DICKINSON
    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

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVALUATION?: YES D.9. RETURNED TO MANUFACTURER ON: 10/1/2021 H.6. INVESTIGATION: THE COMPLAINT WAS CONFIRMED AS THE REPORTED DEFECT ON A RETURNED SAMPLE. WE DIDN'T RECEIVE PHOTO FROM THE CUSTOMER. THE ISSUE WAS CONTAMINATION OF BACILLUS SP. FROM RETURN. NOT CONFIRM INSECT. NO ISSUE IN DEVICE HISTORY RECORD REVIEW. NO ISSUE IN RETENTION SAMPLE. NO TREND WE WILL CONTINUE TO MONITOR THE TREND THIS ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT MOLD/CONTAMINATION WAS FOUND ON THE PLATE MUELLER HINTON AGAR 5% SB 20 EA. AS THE PLATE WAS UNUSED, THERE WERE NO RESULTS TO REPORT, AND THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: "THE CUSTOMER FOUND MOLD IN THE UNUSED MEDIA, AND SIGNS THAT AN INSECT WALKED ON THE LID."

    Additional Manufacturer Narrative · 1

    OEM MANUFACTURE: THE MANUFACTURING LOCATION FOR THIS PRODUCT IS (B)(4). THIS SITE IS AN OEM MANUFACTURING SITE. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED IN AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. 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 · 1

    IT WAS REPORTED THAT MOLD/CONTAMINATION WAS FOUND ON THE PLATE MUELLER HINTON AGAR 5% SB 20 EA. AS THE PLATE WAS UNUSED, THERE WERE NO RESULTS TO REPORT, AND THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "THE CUSTOMER FOUND MOLD IN THE UNUSED MEDIA, AND SIGNS THAT AN INSECT WALKED ON THE LID."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1468334 PLATE MUELLER HINTON AGAR 5% SB 20 EA MUELLER HINTON AGAR/BROTH CULTURE MEDIA ANTIMICROBIAL SUSCEPTIBILITY TEST JTZ BECTON DICKINSON 1152047

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown