BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLATE MUELLER HINTON II AGAR 150MM 20

    MDR report key: 14251280 · Received April 29, 2022

    Report

    Report Number
    9680577-2022-00063
    Event Type
    Malfunction
    Date Received
    April 29, 2022
    Date of Event
    April 4, 2022
    Report Date
    July 15, 2022
    Manufacturer
    BECTON DICKINSON GMBH
    Product Code
    JTZ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT IS UNKNOWN; AWARENESS DATE HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H.6: DEVICE EVALUATION: IT WAS REPORTED WHILE TESTING WITH BD PLATE MUELLER HINTON II AGAR 150MM 20 BIOLOGICAL CONTAMINATION WAS OBSERVED ON THE MEDIA. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE PLATES WERE RECEIVED CRASHED AND WITH GROWING IN THE MEDIA. BEFORE THE USE THE CUSTOMER SAW THAT THE MATERIAL WAS IN NOT OPTIMAL STAGE.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE TESTING WITH BD PLATE MUELLER HINTON II AGAR 150MM 20 BIOLOGICAL CONTAMINATION WAS OBSERVED ON THE MEDIA. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE PLATES WERE RECEIVED CRASHED AND WITH GROWING IN THE MEDIA. BEFORE THE USE THE CUSTOMER SAW THAT THE MATERIAL WAS IN NOT OPTIMAL STAGE.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE TESTING WITH BD PLATE MUELLER HINTON II AGAR 150MM 20 BIOLOGICAL CONTAMINATION WAS OBSERVED ON THE MEDIA. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE PLATES WERE RECEIVED CRASHED AND WITH GROWING IN THE MEDIA. BEFORE THE USE THE CUSTOMER SAW THAT THE MATERIAL WAS IN NOT OPTIMAL STAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    118124 BD PLATE MUELLER HINTON II AGAR 150MM 20 CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST, MUELLER HINTON AGAR/BROTH JTZ BECTON DICKINSON GMBH 2014166

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown