BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD STERILE CULTURE SWAB

    MDR report key: 23631554 · Received November 24, 2025

    Report

    Report Number
    1119779-2025-05464
    Event Type
    Malfunction
    Date Received
    November 24, 2025
    Date of Event
    November 5, 2025
    Report Date
    January 20, 2026
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    KXG
    UDI-DI
    00382902205180
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: THIS MEMO SUMMARIZES THE FINDINGS ON YOUR RECENT COMPLAINT (B)(4) ON PRODUCT 220518 (SWAB STERILE FOR ENVIRONMENTAL MONITOR), BATCH NUMBER KDJV. IT WAS REPORTED THAT THERE HAVE BEEN A FEW INSTANCES WHERE LOT KDJV HAD SEVERAL HITS OF GROWTH AFTER PROCESSING THEM HISTORICAL COMPLAINT DATA FOR SKU 220518 SHOWS NO TREND CONCERNING THE REPORTED ISSUE OVER THE PAST YEAR. A REVIEW OF THE BATCH HISTORY RECORD (BHR) FOR THE REPORTED BATCH CONFIRMS THAT ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THERE WERE NO RELATED QUALITY ISSUES DURING MANUFACTURING OF THE PRODUCT. ALSO, THE RETAIN SAMPLES FOR REPORTED PRODUCT/BATCH WERE ANALYZED, AND NO ANOMALIES WERE DETECTED. NO PHYSICAL RETURNS OR IMAGES WERE AVAILABLE FOR ANALYSIS. BASED ON THE INVESTIGATION, THE COMPLAINT COULD NOT BE CONFIRMED. AS NO COMPLAINT TRENDS ARE PRESENT AT THIS TIME, NO FURTHER ACTION WILL BE TAKEN. BD WILL CONTINUE TO MONITOR TRENDING FOR THIS ISSUE.

    Additional Manufacturer Narrative · 0

    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

    IT WAS REPORTED THAT WHILE USING A BD STERILE CULTURE SWABS, AN UNSPECIFIED NUMBER OF BIOLOGICAL CONTAMINATIONS WERE OBSERVED. THERE WERE NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING A BD STERILE CULTURE SWABS, AN UNSPECIFIED NUMBER OF BIOLOGICAL CONTAMINATIONS WERE OBSERVED. THERE WERE NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2390540 BD STERILE CULTURE SWAB APPLICATOR, ABSORBENT TIPPED, STERILE KXG BECTON DICKINSON & CO. (SPARKS) KDJV 00382902205180

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown