BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATE MUELLER HINTON II AGAR 90MM

    MDR report key: 19749355 · Received July 16, 2024

    Report

    Report Number
    9680577-2024-00020
    Event Type
    Malfunction
    Date Received
    July 16, 2024
    Date of Event
    June 26, 2024
    Report Date
    October 11, 2024
    Manufacturer
    BECTON DICKINSON GMBH
    Product Code
    JTZ
    UDI-DI
    30382902540817
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3. THE ACTUAL DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY THE MANUFACTURER HAS BEEN USED FOR THIS FIELD. UNKNOWN BATCH: D.4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H.4. DEVICE MANUFACTURE DATE: UNKNOWN. 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

    INVESTIGATION SUMMARY THIS MEMO IS TO UPDATE THE SUMMARIZE FINDINGS ON THE COMPLAINT 10419553 AGAINST MUELLER HINTON II AGAR, CATALOG NUMBER 254081, LOT NUMBER UNKNOWN WITH RESPECT TO PERFORMANCE. EVENT DESCRIPTION: THE CUSTOMER REPORTED THAT FOR SOME TIME NOW, THEY HAVE REGULARLY NOTICED GROWTH AROUND SXT DISCS FROM ROSCO. COMPARISON WAS PERFORMED WITH PLATES FROM BIORAD, WHERE DEFINED ZONES WITHOUT ANY GROWTH WERE OBSERVED. COMPLAINT HISTORY REVIEW: THE COMPLAINT HISTORY WAS REVIEWED FOR THE PAST 12 MONTHS, AND TWO SIMILAR COMPLAINTS WERE REGISTERED FOR THIS CATALOG NUMBER. A TREND COULD NOT BE IDENTIFIED. BATCH HISTORY RECORD (BHR) REVIEW: A BATCH HISTORY REVIEW COULD NOT BE PERFORMED WITHOUT A LOT NUMBER. SAMPLE ANALYSIS: WITHOUT A LOT NUMBER, RETAIN SAMPLES COULD NOT BE ANALYZED FOR THE GROWTH PROMOTING ABILITY OF THE MEDIUM. THEREFORE, IN A FIRST TEST, THREE DIFFERENT LOT NUMBERS OF BD MUELLER HINTON II AGAR WERE TESTED USING THE AST METHOD ACCORDING TO EUCAST GUIDELINES. ESCHERICHIA COLI ATCC 25922, ENTEROCOCCUS FAECALIS ATCC 29212 AND STAPHYLOCOCCUS AUREUS ATCC 29213 WERE TESTED WITH SXT SENSI DISKS FROM BD. ALL INHIBITION ZONES WERE EVALUATED TO BE WITHIN THE EUCAST RANGE, NO GROWTH WITHIN THE INHIBITION WAS OBSERVED. RETURN SAMPLES WERE NOT PROVIDED. PICTURE SAMPLES WERE SHARED SHOWING INHIBITION ZONES WITH GROWTH UP TO THE DISC. IN A FURTHER TEST, CLINICAL ISOLATES OF KLEBSIELLA PNEUMONIAE AND ENTEROBACTER CLOACAE PROVIDED BY THE CUSTOMER WERE TESTED: THE CLINICAL ISOLATES WERE TESTED ON BD AND OXOID BATCHES OF MUELLER HINTON II MEDIUM WITH SXT DISKS FROM BOTH BD AND OXOID USING THE AST METHOD ACCORDING TO EUCAST GUIDELINES. ALL STRAINS WERE APPLIED TO BD MUELLER HINTON II MEDIUM LOT NO. 4176296, AND TO OXOID MUELLER HINTON II LOT NO. 4466176, ANTIBIOTIC DISCS BD SXT LOT 3003869 AND OXOID SXT LOT 3794413 WERE ADDED TO THE PLATES. AFTER INCUBATION OF 16-18 HOURS AT 35-37°C UNDER AEROBIC ATMOSPHERE, THE ZONES WERE ANALYZED. IN CASE OF DOUBLE ZONES, THE INNER ZONE WAS USED TO MEASURE THE INHIBITION ZONES ACCORDING TO THE EUCAST GUIDELINES. THE E. CLOACAE ISOLATE SHOWED AN INHIBITION ZONE IN SIZE COMPARABLE FOR BOTH PLATES AND DISCS. NO GROWTH WITHIN THE INHIBITION ZONE WAS OBSERVED. THE K. PNEUMONIAE ISOLATE SHOWED AN INHIBITION ZONE IN SIZE COMPARABLE FOR BOTH PLATES AND DISCS. HOWEVER, FINE HAZE GROWTH WITHIN THE INHIBITION ZONE WAS OBSERVED ON THE BD PLATES. ZONE EDGE HOWEVER WAS CLEARLY VISIBLE. ACCORDING TO THE EUCAST READING GUIDE (EUCAST DISK DIFFUSION METHOD FOR ANTIMICROBIAL SUSCEPTIBILITY TESTING, VERSION 10.0 JANUARY 2023), FOR TRIMETHOPRIM AND TRIMETHOPRIM-SULFAMETHOXAZOLE, IN CASE OF DOUBLE ZONES THE INNER ZONE SHOULD BE READ. FURTHER, FINE HAZE OR FAINT GROWTH UP TO THE DISK WITHIN A ZONE WITH OTHERWISE CLEAR ZONE EDGE SHOULD BE IGNORED. EVALUATION RESULTS: AT THIS STAGE OF OUR INVESTIGATION, WE HAVE EXCLUDED ANY SYSTEMIC FAILURE IN OUR MANUFACTURING PROCESS. NO DEVIATIONS COULD BE DETERMINED NEITHER DURING IN-PROCESS CONTROLS NOR DURING QC RELEASE OF THE CORRESPONDING BATCH NUMBERS. ADDITIONALLY, NO DEVIATION COULD BE FOUND NEITHER DURING THE QC PERFORMANCE TESTING NOR DURING OUR RETEST ON THE RETAIN SAMPLES OF LOT NUMBER 4176296 WITH THE BD ATCC STRAINS AND THE CUSTOMER STRAINS. INVESTIGATION CONCLUSION: BASED ON THE PROVIDED PICTURE SAMPLES, THIS COMPLAINT IS CONFIRMED FOR A PERFORMANCE ISSUE. HOWEVER, NO DEVIATION COULD BE FOUND NEITHER DURING THE QC PERFORMANCE TESTING NOR DURING OUR RETEST ON THE RETAIN SAMPLES OF LOT NUMBER 4176296 WITH THE BD ATCC STRAINS AND THE CUSTOMER STRAINS.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING PLATE MUELLER HINTON II AGAR 90MM THAT THERE WAS EXCESSIVE GROWTH WHEN USING ROSCO SXT (CO-THRIMOXAZOLE) DISCS. THIS OCCURRED WITH AN UNSPECIFIED NUMBER OF PLATES. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING PLATE MUELLER HINTON II AGAR 90MM THAT THERE WAS EXCESSIVE GROWTH WHEN USING ROSCO SXT (CO-THRIMOXAZOLE) DISCS. THIS OCCURRED WITH AN UNSPECIFIED NUMBER OF PLATES. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    721973 PLATE MUELLER HINTON II AGAR 90MM CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST, MUELLER HINTON AGAR JTZ BECTON DICKINSON GMBH UNKNOWN 30382902540817

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown