BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BBL CHROMAGAR ORIENTATION 90MM

    MDR report key: 21139864 · Received January 13, 2025

    Report

    Report Number
    9680577-2025-00001
    Event Type
    Malfunction
    Date Received
    January 13, 2025
    Date of Event
    December 19, 2024
    Report Date
    January 3, 2025
    Manufacturer
    BECTON DICKINSON GMBH
    Product Code
    JSH
    UDI-DI
    30382902541074
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: THIS MEMO IS TO SUMMARIZE FINDINGS ON YOUR RECENT COMPLAINT (B)(4). AGAINST BD BBL CHROMAGAR ORIENTATION AGAR, CATALOG NUMBER 254107, LOT NUMBER 4274498 WITH RESPECT TO A PERFORMANCE ISSUE. EVENT DESCRIPTION: THE CUSTOMER COMPLAINED ABOUT UNUSUAL COLONIES COLORS. ALL COLONIES OF DIFFERENT BACTERIA LIKE E. COLI, KLEBSIELLA, ENTEROBACTER AND CITROBACTER GREW WITH THE SAME COLOR- WHITE- LIGHT BLUE. COMPLAINT HISTORY REVIEW: THE COMPLAINT HISTORY OF THE LAST 12 MONTHS WAS REVIEWED, AND SIMILAR PERFORMANCE COMPLAINTS WERE IDENTIFIED FOR THIS CATALOG NUMBER; HOWEVER, A TREND WAS NOT IDENTIFIED. BATCH HISTORY RECORD (BHR) REVIEW: THE BATCH HISTORY RECORD WAS REVIEWED. NO DEVIATIONS FROM THE VALIDATED PROCESS PARAMETERS WERE DETECTED. RELEASE TESTING BY THE QC DEPARTMENT WAS SATISFACTORY. INITIAL SAMPLE ANALYSIS: WITHIN THE COMPLAINT INVESTIGATION, RETAINMENT SAMPLES OF LOT 4274498 WERE ANALYZED ACCORDING TO THE QUALITY CONTROL RELEASE PARAMETERS. ALL TESTED STRAINS GREW ACCORDING TO THE SPECIFICATION, AFTER INCUBATION AEROBICALLY FOR 18-24 H AT 35-37 °C IN THE DARK. ESCHERICHIA COLI ATCC 25922 TEST STRAIN SHOWED ROSE TO PINK COLONIES, ENTEROBACTER CLOACAE ATCC 13047 TEST STRAIN SHOWED LARGE, BLUE COLONIES, KLEBSIELLA PNEUMONIAE ATCC 33495 TEST STRAIN SHOWED LARGE, BLUE, MUCOID COLONIES, PROTEUS MIRABILIS ATCC 43071 TEST STRAIN SHOWED BEIGE, SURROUNDED BY BEIGE TO BROWNISH HALOS COLONIES, AS DESCRIBED IN THE CERTIFICATE OF ANALYSIS (COA). RETURN SAMPLES WERE NOT PROVIDED BY THE CUSTOMER. PICTURE SAMPLES, PROVIDED BY THE CUSTOMER, SHOWS PLATES OF LOT 4274498 WITH GROWTH OF WHITE TO LIGHT BLUE COLONIES. EVALUATION RESULTS: AT THIS STAGE OF OUR INVESTIGATION, WE HAVE EXCLUDED ANY SYSTEMIC FAILURE IN OUR PRODUCTION PROCESS. NO DEVIATION COULD BE FOUND DURING THE QC RELEASE PERFORMANCE TEST AND THE PERFORMANCE TEST ON THE RETAIN SAMPLES. PLEASE TAKE CARE THAT THE CHROMAGAR ORIENTATION PLATES SHOULD BE STORED IN THE DARK, AS THIS MAY HAVE AN INFLUENCE ON THE RESULT. INVESTIGATION CONCLUSION: BASED UPON OUR INVESTIGATION ON RETAIN SAMPLES, THE COMPLAINT CANNOT BE CONFIRMED FOR A PERFORMANCE ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING PLATE BBL CHROMAGAR ORIENTATION 90MM THAT AN UNSPECIFIED NUMBER OF PATIENT SAMPLES GREW BACTERIA IN ATYPICAL WHITE TO LIGHT BLUE COLONIES. THIS WAS REPORTED TO HAVE OCCURRED WITH MULTIPLE ORGANISMS INCLUDING E. COLI, KLEBSIELLA, ENTEROBACTER, AND CITROBACTER. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    498365 BBL CHROMAGAR ORIENTATION 90MM CULTURE MEDIA, NON-SELECTIVE AND DIFFERENTIAL JSH BECTON DICKINSON GMBH 4274498 30382902541074

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown