BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD STERILE CULTURE SWAB

    MDR report key: 21950958 · Received May 2, 2025

    Report

    Report Number
    1119779-2025-00350
    Event Type
    Malfunction
    Date Received
    May 2, 2025
    Date of Event
    April 23, 2025
    Report Date
    August 25, 2025
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    KXG
    UDI-DI
    00382902205180
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: THIS MEMO SERVES TO SUMMARIZE FINDINGS ON YOUR RECENT COMPLAINT (B)(4) ON PRODUCT 220518 (SWAB STERILE FOR ENVIRONMENTAL MONITORING), LOT NUMBER D2MJ, WHERE IT WAS OBSERVED THAT THERE WAS CONTAMINATION FROM MICROORGANISMS. EVENT DESCRIPTION: IT WAS REPORTED THAT MICROORGANISMS ARE FREQUENTLY DETECTED IN POST-USE MICROBIAL TESTS. COMPLAINT HISTORY REVIEW: A REVIEW OF PAST COMPLAINTS ON THIS PRODUCT OVER THE PAST 12 MONTHS DOES NOT INDICATE A TREND ON THIS ISSUE. DEVICE HISTORY RECORD REVIEW: A REVIEW OF THE DEVICE HISTORY RECORD DOES NOT INDICATE ANY MANUFACTURING ISSUES. SAMPLE ANALYSIS: NO PHOTOS OR RETURNS WERE AVAILABLE. THE RETENTION SAMPLES DID NOT EXHIBIT ANY DEFECTS. EVALUATIONS RESULTS: BASED ON THE INVESTIGATION, NO DEFECT WAS OBSERVED. THERE IS NO SYSTEMIC FAILURE IN THE MANUFACTURING PROCESS. THERE IS NO COMPLAINT TREND PRESENT FOR THIS ISSUE WITH THIS PRODUCT. INVESTIGATION CONCLUSION: BASED ON THE EVALUATION OF THE INVESTIGATION, THE COMPLAINT WAS NOT CONFIRMED. AS NO DEVIATIONS WERE OBSERVED IN THE INVESTIGATION, NO CORRECTIVE OR PREVENTIVE ACTIONS ARE INDICATED AT THIS TIME. NO FURTHER ACTIONS WILL BE TAKEN. BD WILL CONTINUE TO MONITOR FOR TRENDING.

    Additional Manufacturer Narrative · 0

    B3. THE ACTUAL DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY THE MANUFACTURER HAS BEEN USED FOR THIS FIELD. THE MANUFACTURING LOCATION FOR THIS PRODUCT IS COPAN, ITALIA. THIS SITE IS AN OEM MANUFACTURING SITE. THEREFORE, BD CORPORATE HEADQUARTERS IN SPARKS, MD HAS BEEN LISTED IN SECTIONS D.3. AND G.1. AND THE SPARKS FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. 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

    REPORT 5 OF 10: IT WAS REPORTED WHILE USING A BD STERILE CULTURE SWABS THAT BIOLOGICAL CONTAMINATION WAS OBSERVED. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Description of Event or Problem · 0

    REPORT 5 OF 10: IT WAS REPORTED WHILE USING A BD STERILE CULTURE SWABS THAT BIOLOGICAL CONTAMINATION WAS OBSERVED. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    208186 BD STERILE CULTURE SWAB APPLICATOR, ABSORBENT TIPPED, STERILE KXG BECTON DICKINSON & CO. (SPARKS) D2MJ 00382902205180

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown