BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MUELLER HINTON II AGAR, PLATE, 90 MM X 20

    MDR report key: 19082178 · Received April 10, 2024

    Report

    Report Number
    9680577-2024-00008
    Event Type
    Malfunction
    Date Received
    April 10, 2024
    Date of Event
    March 13, 2024
    Report Date
    March 22, 2024
    Manufacturer
    BECTON DICKINSON GMBH
    Product Code
    JTZ
    UDI-DI
    30382902540329
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: EVENT DESCRIPTION: THE CUSTOMER REPORTS THAT THERE IS A LAWN FORMATION WITHIN THE INHIBITION ZONE ON THE MUELLER HINTON AGAR WITH THE ANTIBIOTIC SXT (SULFAMETHOXAZOLE TRIMETHOPRIM). COMPLAINT HISTORY REVIEW: THE COMPLAINT HISTORY WAS REVIEWED FOR THE PAST 12 MONTHS, AND NO SIMILAR COMPLAINTS WERE REGISTERED FOR THIS CATALOG NUMBER. A TREND COULD NOT BE IDENTIFIED. BATCH HISTORY RECORD (BHR) REVIEW: THE BATCH HISTORY REVIEW DID NOT INDICATE ANY DISCREPANCIES. ALL RELEASE TESTING WAS SATISFACTORY, AND NO DEVIATIONS WERE OBSERVED. SAMPLE ANALYSIS: RETAIN SAMPLES WERE ANALYZED FOR THE GROWTH PROMOTING ABILITY OF THE MEDIUM. ESCHERICHIA COLI ATCC 25922 AND TRIMETHOPRIM-SULFAMETHOXAZOLE SXT-1.25-23.75 USED FOR QUALITY RELEASE TESTING OF CATALOG NUMBER 254032 AND RECOMMENDED FOR USER QUALITY CONTROL OF THE MEDIUM WAS APPLIED TO MEDIUM OF LOT NO. 4008597. BACTERIAL SUSPENSIONS USED FOR TESTING WERE ADJUSTED TO A MCFARLAND OF 0.5 ± 0.05. AFTER INCUBATION OF 16-18 HOURS AT 35-37 °C UNDER AEROBIC ATMOSPHERE, THE INHIBITED ZONES ARE WITHIN SPECIFICATION WITHOUT ANY DEVIATION. THE TESTING WAS PERFORMED ACCORDING TO EUCAST. NO RETURN SAMPLES WERE PROVIDED BY THE CUSTOMER FOR ANALYSIS. A PICTURE WAS SHARED SHOWING A PLATE OF MUELLER HINTON II AGAR WITH A SENSIDISC AND A CLEAR INHIBITION ZONE THAT, HOWEVER, IS SURROUNDED BY A SECOND ZONE WITH FINE LAWN FORMATION. ON THE PICTURE, A SECOND PLATE FROM ANOTHER MANUFACTURER WITH A SENSIDISC AND A CLEAR INHIBITION ZONE WAS SHOWN AS WELL. EVALUATION RESULTS: AT THIS STAGE OF THE INVESTIGATION, ANY SYSTEMIC FAILURE IN THE MANUFACTURING PROCESSES CAN BE EXCLUDED. NO DEVIATION COULD BE FOUND NEITHER DURING THE QC PERFORMANCE TESTING NOR DURING OUR RETEST ON THE RETAIN SAMPLES. SINCE NO TREND WAS IDENTIFIED, NO CORRECTIVE OR PREVENTIVE ACTION WILL BE IMPLEMENTED THIS TIME. ACCORDING TO THE EUCAST READING GUIDE PUBLISHED IN JAN 2023 (READING GUIDE: ¿EUCAST DISK DIFFUSION METHOD FOR ANTIMICROBIAL SUSCEPTIBILITY TESTING¿ VERSION 10.0, JANUARY 2023) DOUBLE ZONES CAN APPEAR FOR THE USE WITH TRIMETHOPRIM AND TRIMETHOPRIM-SULFAMETHOXAZOLE. THE RECOMMENDATION IS TO READ THE INNER ZONE. INVESTIGATION CONCLUSION: BASED ON THE EVALUATION OF THE REPORT AND ON THE RESULTS OF THE DISC DIFFUSION TEST USING THE RETAIN SAMPLES, THE COMPLAINT CANNOT BE CONFIRMED FOR A PERFORMANCE ISSUE. HOWEVER, BD WILL CONTINUE TO MONITOR INCOMING COMPLAINTS FOR SIMILAR FAILURE TYPES TO DETERMINE IF FURTHER ACTIONS ARE NEEDED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING THE BD MUELLER HINTON II AGAR, PLATE, 90 MM X 20 THE USER NOTED A PERFORMANCE FAILURE. THERE WAS A SECONDARY BACTERIAL LAWN FORMATION WITHIN THE INHIBITION ZONE WHILE USING THE ANTIBIOTIC SXT (SULFAMETHOXAZOLE TRIMETHOPRIM). NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1230825 BD MUELLER HINTON II AGAR, PLATE, 90 MM X 20 CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST, MUELLER HINTON AGAR/BROTH JTZ BECTON DICKINSON GMBH 4008597 30382902540329

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown