BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATE MUELLER HINTON II AGAR 90MM 20

    MDR report key: 11417610 · Received March 4, 2021

    Report

    Report Number
    9680577-2021-00007
    Event Type
    Malfunction
    Date Received
    March 4, 2021
    Date of Event
    February 5, 2021
    Report Date
    November 8, 2021
    Manufacturer
    BECTON DICKINSON GMBH
    Product Code
    JTZ
    PMA / PMN Number
    PREAMENDMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THE ZONE OF THE INHIBITION WOULD BE TO SMALL. THE COMPLAINT HISTORY WAS REVIEWED. DURING THIS PERIOD, NO FURTHER COMPLAINTS WERE REPORTED FOR THIS PRODUCT BATCH FOR PERFORMANCE RELATED ISSUES. THEREFORE, A TREND COULD NOT BE IDENTIFIED. THE BATCH HISTORY RECORD REVIEW DID NOT SHOW ANY DISCREPANCIES. PICTURE SAMPLE WAS NOT PROVIDED. AN ANALYSIS OF GROWTH PROMOTION FOR THE MEDIA WAS PERFORMED ON RETENTION SAMPLES FOR BATCH 0336360 AND NO DEVIATIONS WERE DETECTED REGARDING THE INHIBITION ZONE. AT THIS STAGE OF OUR INVESTIGATION, WE HAVE EXCLUDED ANY SYSTEMIC FAILURE IN OUR PRODUCTION PROCESS. THE QC PERFORMANCE TEST WAS PERFORMED FOR E.COLI ATCC 25922 WITHOUT ANY DEVIATIONS. BASED ON THE EVALUATION OF THE REPORTS, AND THE QC PERFORMANCE TEST THE COMPLAINT WAS NOT CONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING PLATE MUELLER HINTON II AGAR 90MM 20 ATYPICAL GROWTH WAS OBSERVED BY THE LABORATORY PERSONNEL. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. PMA / 510(K)#: THIS PRODUCT IS SIMILAR TO CATALOG NUMBER 221177. THE 510K INFORMATION FOR 221177 HAS BEEN INCLUDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING PLATE MUELLER HINTON II AGAR 90MM 20 ATYPICAL GROWTH WAS OBSERVED BY THE LABORATORY PERSONNEL. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313924 PLATE MUELLER HINTON II AGAR 90MM 20 CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL JTZ BECTON DICKINSON GMBH 0336360

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown