BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ CHROMAGAR¿ ORIENTATION AGAR

    MDR report key: 22949481 · Received September 3, 2025

    Report

    Report Number
    9614033-2025-00089
    Event Type
    Malfunction
    Date Received
    September 3, 2025
    Date of Event
    September 5, 2024
    Report Date
    July 10, 2025
    Manufacturer
    BECTON DICKINSON DE MEXICO
    Product Code
    JSH
    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

    E1. INITIAL REPORTER ADDRESS: (B)(6). INVESTIGATION SUMMARY: THE COMPLAINT REPORT RECEIVED FOR CATALOG 252631 IS CLASSIFIED AS CONFIRMED FOR THE PRESENCE OF CONTAMINATION BASED ON THE EVIDENCE SHARED BY THE CUSTOMER. REVIEW OF BATCH HISTORY RECORDS: THE BATCH FILE REPORTED BY THE CUSTOMER WAS REVIEWED, AND IT WAS OBSERVED THAT, ACCORDING TO THE COLLECTED INFORMATION, THE DEFINED PROCESS CONTROLS WERE CARRIED OUT, AND THE ABSENCE OF CONTAMINATED PRODUCT WAS VERIFIED. REVIEW OF COMPLAINT HISTORY: A REVIEW OF THE COMPLAINT HISTORY FOR A PERIOD OF 2 YEARS WAS CONDUCTED, IDENTIFYING A SERIES OF REPORTS NOT ATTRIBUTABLE TO IN-PLANT HANDLING, SO NO TREND IN THE DEFECT IS IDENTIFIED. RETURNED SAMPLE ANALYSIS: FOR IMAGE 1, THE CUSTOMER PRESENTS AN ANALYSIS FOR THE REPORTED BATCHES. FOR ONE OF THE PLATES, MICROBIOLOGICAL GROWTH IS OBSERVED (BATCH 4201102). BATCH 4201102: FOR THIS BATCH, THE CUSTOMER PRESENTS EVIDENCE OF 2 PLATES WITH MICROBIAL GROWTH. FOR THE FIRST PLATE, THE PRESENCE OF A SINGLE CFU IS OBSERVED, WHILE THE SECOND PHOTOGRAPH SHOWS MORE EXTENSIVE MICROBIOLOGICAL GROWTH. FOR BOTH PRODUCT BATCHES, THE CUSTOMER IDENTIFIES THE BACTERIUM ACINETOBACTER JOHNSONII. HOWEVER, THIS CANNOT BE CONFIRMED DUE TO THE LACK OF RETURNED PHYSICAL SAMPLES. THIS MICROORGANISM IS COMMONLY FOUND IN THE ENVIRONMENT. RETENTION SAMPLE ANALYSIS: IN ACCORDANCE WITH THE LABORATORY ANALYSIS REQUESTS, THE VERIFICATION OF THE APPEARANCE AND BIOLOGICAL LOAD OF THE RETENTION SAMPLES WAS CARRIED OUT, OBTAINING SATISFACTORY RESULTS FOR BOTH TESTS AS NO EVIDENCE OF MICROBIOLOGICAL GROWTH OR VARIATIONS IN THE APPEARANCE OF THE CULTURE MEDIUM FOR EACH BATCH WAS OBSERVED. CONCLUSION: THE COMPLAINT REPORT RECEIVED FOR CATALOG 252631 IS CLASSIFIED AS CONFIRMED, AS THE PRESENCE OF 2 SUPERFICIALLY CONTAMINATED PLATES IS OBSERVED FOR EACH REPORTED BATCH. THIS DEFECT IS WITHIN THE ESTABLISHED AQL. ACCORDING TO THE DOCUMENT REVIEW, ALL DEFINED CONTROLS FOR THE PRODUCTS WERE MET, COMPLYING WITH THE ACCEPTANCE CRITERIA FOR APPEARANCE AND WITHOUT CONTAMINATION FOR THE REST OF EACH BATCH. THEREFORE, IT IS POSSIBLE TO AFFIRM THAT THE FAILURE WAS DUE TO A SPECIFIC EVENT IN TIME. HOWEVER, THE PRESENCE OF A CONTAMINATED PACKAGE (1 PLATE) BASED ON THE BATCH SIZE IS CONSIDERED WITHIN THE AQL (ACCEPTANCE QUALITY LEVEL), WHICH IS DEFINED AS 2.5 FOR MAJOR DEFECTS OF SUPERFICIAL BACTERIAL CONTAMINATION. ON THE OTHER HAND, SINCE THE PRODUCT IS NOT CONSIDERED STERILE, IT IS POSSIBLE THAT DURING THE STORAGE PROCESS, A CFU MAY BE CARRIED OVER DUE TO CONDENSATES GENERATED DURING STORAGE OR DISTRIBUTION. BD WILL CONTINUE TO MONITOR TRENDS. THIS MDR IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW OF RECORDS DATING APRIL 2023-2025, UNDER CAPA 11910483.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD BBL¿ CHROMAGAR¿ ORIENTATION AGAR, THERE WERE AN UNKNOWN NUMBER OF FALSE RESULTS DUE TO CONTAMINATION. THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2233917 BD BBL¿ CHROMAGAR¿ ORIENTATION AGAR CULTURE MEDIA, NON-SELECTIVE AND DIFFERENTIAL JSH BECTON DICKINSON DE MEXICO 4201102

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown