BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATE MUELLER HINTON II AGAR 20 EA

    MDR report key: 15089093 · Received July 22, 2022

    Report

    Report Number
    1119779-2022-01018
    Event Type
    Malfunction
    Date Received
    July 22, 2022
    Date of Event
    June 28, 2022
    Report Date
    October 21, 2022
    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

    IN THIS MDR, BD DS HEADQUARTERS IN (B)(6) HAS BEEN LISTED AS FUKUSHIMA 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

    H6 INVESTIGATION SUMMARY: WE CONFIRMED CONTAMINATION FROM RETURNED SAMPLE. DEVICE HISTORY RECORD/ BATCH HISTORY RECORD REVIEW WAS ACCEPTABLE NO ISSUE IN RETENTION, ALTHOUGH IT WAS ALREADY EXPIRED WHEN WE RECEIVED RETURNED SAMPLE. ROOT CAUSE WAS UNDETERMINED. WE WILL CONTINUE TO MONITOR THIS ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING 2 PLATE MUELLER HINTON II AGAR 20 EA CONTAMINATION WAS OBSERVED BY THE LABORATORY PERSONNEL. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THIS IS A REPORT ABOUT MEDIA CONTAMINATION."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING 2 PLATE MUELLER HINTON II AGAR 20 EA CONTAMINATION WAS OBSERVED BY THE LABORATORY PERSONNEL. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THIS IS A REPORT ABOUT MEDIA CONTAMINATION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106519 PLATE MUELLER HINTON II AGAR 20 EA CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST JTZ BECTON, DICKINSON & CO. (SPARKS) 2088793

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown