BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ MACCONKEY AGAR

    MDR report key: 23975764 · Received January 6, 2026

    Report

    Report Number
    9614033-2025-00128
    Event Type
    Malfunction
    Date Received
    January 6, 2026
    Date of Event
    December 9, 2025
    Report Date
    February 4, 2026
    Manufacturer
    BD CUAUTITLAN
    Product Code
    JSI
    UDI-DI
    00382902116622
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: THE COMPLAINT FOR CATALOG NUMBER 211662, BATCH 5224928, IS CLASSIFIED AS NOT CONFIRMED FOR FUNCTIONALITY DEFECT BASED ON THE EVIDENCE PROVIDED BY THE CUSTOMER. BATCH HISTORY RECORD REVIEW: ACCORDING TO THE INFORMATION REVIEWED, NO RECORDS OR REPORTS OF INCIDENTS WERE IDENTIFIED WITHIN THE QUALITY SYSTEM THAT COULD HAVE GENERATED OR CONTRIBUTED TO THE REPORTED DEFECTS. PRODUCT CONDITIONS PRIOR TO RELEASE TO THE WAREHOUSE WERE VERIFIED WITH NO FINDINGS DETECTED. COMPLAINT HISTORY REVIEW: FOR A TWO YEAR PERIOD, NO COMPLAINTS RELATED TO THE DEFECT WERE IDENTIFIED. QUALITY EVENTS REVIEW: A REVIEW OF THE QN HISTORY FOR THE PAST TWO YEARS WAS PERFORMED, WITH NO DETECTION OF FUNCTIONALITY DEFECTS FOR THE MEDIUM ASSOCIATED WITH THE REPORTED CATALOG. RETURNED SAMPLE ANALYSIS: THE CUSTOMER PROVIDED THREE PHOTOGRAPHS RELATED TO THE DEFECT. IMAGE 1: THE LABEL OF A PACKAGE OF PETRI DISHES IS SHOWN. ALTHOUGH THE CHARACTERISTICS OF THE MEDIUM CANNOT BE OBSERVED, BATCH 5224928, CORRESPONDING TO THE LOT REPORTED BY THE CUSTOMER, IS VISIBLE. IMAGE 2: A PETRI PLATE CONTAINING CULTURE MEDIUM IS SHOWN, WITH CHARACTERISTICS CONSISTENT WITH THE PRODUCT CATALOG REFERENCED BY THE CUSTOMER. LOT 5224928 AND PLATE NUMBER 1208 CAN BE IDENTIFIED. THE MEDIUM SHOWS NO SIGNIFICANT GROWTH: NO DEFINED COLONIES ARE OBSERVED, ONLY STREAK MARKS. IMAGE 3: A PLATE CONTAINING CULTURE MEDIUM IS SHOWN, WITH CHARACTERISTICS CONSISTENT WITH THE PRODUCT CATALOG REFERENCED BY THE CUSTOMER. THE PLATE CONTAINS AN IDENTIFICATION LABEL: HOWEVER, NO LOT NUMBER OR BD ASSIGNED CODE CAN BE DISTINGUISHED. RETENTION SAMPLE ANALYSIS: NOT APPLICABLE. NO ADDITIONAL FUNCTIONALITY VERIFICATION IS REQUIRED FOR RETENTION SAMPLES, SINCE THE EVALUATED MEDIUM IS NOT INTENDED FOR YEAST DIFFERENTIATION. THE PRODUCT QUALITY CONTROL SCOPE COVERS THE MEDIUMS TARGET MICROORGANISMS ACCORDING TO ITS INTENDED USE. CONCLUSION: THE CLAIM IS CLASSIFIED AS NOT CONFIRMED (NC). BASED ON THE EVIDENCE PROVIDED AND THE INOCULATION TECHNIQUE OBSERVED. THE PATTERN CORRESPONDS TO SURFACE STREAKING, NOT AN ACCIDENTAL DEPOSIT, WHICH CONFIRMS DELIBERATE INOCULATION AND RULES OUT CONTAMINATION AS THE SOURCE OF THE GROWTH. THE OBSERVED MARKS ARE LINEAR/ZIGZAG STREAKS VISIBLE IN THE UPPER AREA OF THE PLATE. THE GROWTH CORRESPONDS TO INTENTIONAL INOCULATION OF YEAST ON MACCONKEY AGAR PLATES: THIS IS NOT CONTAMINATION. ADDITIONALLY, FAINT GROWTH OR SMALL COLONIES MAY OCCUR WHEN YEASTS ARE INOCULATED ON MACCONKEY, SINCE THIS MEDIUM IS NOT FORMULATED TO OPTIMIZE FUNGAL DEVELOPMENT. THESE FINDINGS DO NOT DEMONSTRATE A PRODUCT DEFECT, BECAUSE MACCONKEY AGAR IS A SELECTIVE AND DIFFERENTIAL MEDIUM FOR ENTERIC GRAM NEGATIVE BACILLI (SELECTIVITY DUE TO BILE SALTS AND CRYSTAL VIOLET: DIFFERENTIATION BY LACTOSE FERMENTATION WITH NEUTRAL RED) AND IS NOT INTENDED FOR THE RECOVERY/DIFFERENTIATION OF YEASTS. THEREFORE, THE EVENT IS ATTRIBUTED TO USE OUTSIDE THE INTENDED PURPOSE AND IS UNRELATED TO THE MANUFACTURING PROCESS OR THE MEDIUMS QUALITY CONTROLS. BD WILL CONTINUE MONITORING TO IDENTIFY TRENDS.

    Additional Manufacturer Narrative · 0

    E1. INITIAL REPORTER PHONE # (B)(6). 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 WHILE USING ONE (1) BD BBL¿ MACCONKEY II AGAR, THERE WAS UNEXPECTED CANDIDA PARAPSILOSIS GROWTH. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING ONE (1) BD BBL¿ MACCONKEY II AGAR, THERE WAS UNEXPECTED CANDIDA PARAPSILOSIS GROWTH. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37693 BD BBL¿ MACCONKEY AGAR CULTURE MEDIA, SELECTIVE AND DIFFERENTIAL JSI BD CUAUTITLAN 5224928 00382902116622

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown