BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ MUELLER HINTON II AGAR

    MDR report key: 19184758 · Received April 25, 2024

    Report

    Report Number
    9680577-2024-00010
    Event Type
    Malfunction
    Date Received
    April 25, 2024
    Date of Event
    March 28, 2024
    Report Date
    May 6, 2024
    Manufacturer
    BECTON DICKINSON GMBH
    Product Code
    JTZ
    UDI-DI
    30382902540817
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: THIS MEMO IS TO SUMMARIZE FINDINGS ON YOUR RECENT COMPLAINT (B)(4) AGAINST BD MUELLER HINTON II AGAR, CATALOG NUMBER 254081, LOT NUMBER 4051079 WITH RESPECT TO PERFORMANCE ISSUE. EVENT DESCRIPTION: THE CUSTOMER REPORTED THAT THERE IS NO CLEAR INHIBITION ZONE ON BD MUELLER HINTON II AGAR. THE CUSTOMER USUALLY USES BD MH II MEDIA IN COMBINATION WITH BD SENSIDISCS. BECAUSE OF THE SENSIDISC BACKORDER SITUATION, ANTIBIOTIC DISCS FROM BIORAD WERE USED. THE CUSTOMER REPORTS AN UNCLEAR INHIBITION ZONE OF TRIMETHOPRIM-SULFAMETHOXAZOL FROM BIORAD ON BD MH II PLATES WHEREAS THE EFFECT WAS NOT OBSERVED ON BIOMERIEUX PLATES. COMPLAINT HISTORY REVIEW: THE COMPLAINT HISTORY WAS REVIEWED FOR THE PAST 12 MONTHS, AND SIMILAR COMPLAINTS (I.E. DEFECT CODE PERFORMANCE) WERE REGISTERED FOR THIS CATALOG NUMBER. NO TREND WAS OBSERVED, 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 ENTEROCOCCUS FAECALIS ATCC 29212 STRAINS WITH TRIMETHOPRIM-SULFAMETHOXAZOLE (SXT-1.25-23.75) USED FOR QUALITY RELEASE TESTING OF CATALOG NUMBER 254081 AND RECOMMENDED FOR USER QUALITY CONTROL OF THE MEDIUM WERE APPLIED TO MEDIUM OF LOT NO. 4051079. AFTER INCUBATION FOR 16-18 HOURS AT 35-37°C UNDER AEROBIC ATMOSPHERE, THE INHIBITED ZONES ARE WITHIN SPECIFICATION WITHOUT ANY DEVIATION. THE DESCRIBED HAZE COULD NOT BE OBSERVED. THE TESTING WAS PERFORMED ACCORDING TO EUCAST. NO RETURN SAMPLES WERE PROVIDED BY THE CUSTOMER FOR ANALYSIS. PICTURES WERE SHARED COMPARING BD MUELLER HINTON II AGAR AND BIOMERIEUX MUELLER HINTON AGAR OCCUPIED WITH DIFFERENT STRAINS AND SENSIDISC SXT25. STRAINS USED ARE ESCHERICHIA COLI ATCC 25922, KLEBSIELLA PNEUMONIAE (PAT.- ISOLATE), ESCHERICHIA COLI (PAT.- ISOLATE) AND STAPHYLOCOCCUS AUREUS ATCC 29213. THE INHIBITION ZONES OF THE PATIENT ISOLATE STRAINS WERE HAZY ON THE BD PLATES BUT CLEAR ON THE BIOMERIEUX PLATES. INHIBITION ZONES WERE CLEAR FOR THE E.COLI AND S. AUREUS ATTC STRAINS ON BOTH BD AND BIOMERIEUX PLATES. 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. BATCH HISTORY RECORD REVIEW DID NOT REVEAL ANY SIGNALS THAT COULD LEAD TO THE DESCRIBED DEFECT. ACCORDING TO THE INSTRUCTIONS FOR USE FOR BD MUELLER HINTON II AGAR WITH SOME ORGANISM AGENT COMBINATIONS, THE INHIBITION ZONE MAY NOT HAVE A SHARPLY DEMARCATED EDGE, WHICH CAN LEAD TO INCORRECT INTERPRETATION. VARIOUS FACTORS HAVE BEEN IDENTIFIED AS INFLUENCING DISC DIFFUSION SUSCEPTIBILITY TEST. HOWEVER, IN A PROCESS OF CONTINUOUS IMPROVEMENT AND REGARDING SIMILAR COMPLAINTS RECEIVED, A CROSS-FUNCTIONAL TEAM IS CURRENTLY FURTHER INVESTIGATING THE DESCRIBED DEFECT. AT THIS STAGE, A ROOT CAUSE HAS NOT BEEN IDENTIFIED. INVESTIGATION CONCLUSION: BASED ON THE EVALUATION OF THE REPORT AND ON THE RECEIVED SAMPLE PICTURES, THE COMPLAINT IS CONFIRMED FOR A PERFORMANCE ISSUE. BD WILL CONTINUE TO CLOSELY MONITOR INCOMING COMPLAINTS FOR SIMILAR FAILURE TYPES AND INVESTIGATE THE ISSUE WITHIN A CROSS-FUNCTIONAL TEAM.

    Additional Manufacturer Narrative · 0

    H.3. 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 · 0

    IT WAS REPORTED WHEN USING THE BD BBL¿ MUELLER HINTON II AGAR PLATES DO NOT SHOW A CLEAR ZONE OF INHIBITION. THERE WAS NO REPORT OF IMPACT TO THE PATIENT OR USER.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD BBL¿ MUELLER HINTON II AGAR PLATES DO NOT SHOW A CLEAR ZONE OF INHIBITION. THERE WAS NO REPORT OF IMPACT TO THE PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1606251 BD BBL¿ MUELLER HINTON II AGAR CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST JTZ BECTON DICKINSON GMBH 4051079 30382902540817

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown