BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BBL¿ CULTURESWAB¿ PLUS

    MDR report key: 24248549 · Received February 3, 2026

    Report

    Report Number
    1119779-2026-00051
    Event Type
    Malfunction
    Date Received
    February 3, 2026
    Date of Event
    September 30, 2025
    Report Date
    March 6, 2026
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    JSL
    UDI-DI
    00382902201175
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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) FOR PRODUCT 220117 (CULTURE SWAB PLUS AMIES W/O CHARC DOUBLE), BATCH NUMBER 241676200. IT WAS REPORTED BY CUSTOMER THAT CONTAMINATION OF YEAST IN TISSUE CULTURES WHEN USING LOT # 241676200. CUSTOMER DETERMINED THAT THE INCREASE IN YEAST POSITIVE RESULTS WAS NOT FROM THEIR PROCESSING LAB, MEDICAL LOCATIONS, EMPLOYEES, OR PHYSICAL OFFICES 20 POSITIVE YEAST RESULTS FROM 1 PACK OF 50 SWABS. THE CUSTOMER SWABBED 2 TISSUES TWICE: FIRST TIME BOTH TISSUES WERE SWABBED WITH ISSUE LOT AND WERE POSITIVE FOR YEAST. SECOND SWAB WAS SENT TO CELL TX FOR TESTING - ONE SWAB FROM ISSUE LOT, THE OTHER FROM A DIFFERENT LOT. ONLY THE SWAB FROM THE ISSUE SWAB CAME FROM THE ISSUE LOT WAS POSITIVE FOR YEAST. HISTORICAL COMPLAINT DATA FOR SKU 220117 SHOWS NO TREND CONCERNING THE REPORTED ISSUE OVER THE PAST YEAR. A BHR (BATCH HISTORY RECORD) REVIEW RELATED TO THE PRODUCTION OF THE CLAIMED LOT WAS REVIEWED AND NO DEVIATIONS WERE FOUND EITHER DURING THE PRODUCTION PROCESS NOR DURING THE FINAL CHECKS FOR LOT RELEASE. RETAIN SAMPLES HAVE BEEN RETRIEVED AND NO VISIBLE ANOMALY HAS BEEN DETECTED. NO PHYSICAL RETURNS OR IMAGES WERE PROVIDED BY THE CUSTOMER FOR EVALUATION. BASED ON THE INVESTIGATION AND LACK OF DETAILED INFORMATION REGARDING THE TEST PERFORMED BY THE CUSTOMER, A ROOT CAUSE COULD NOT BE DETERMINED, AND 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

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. THE MANUFACTURING LOCATION FOR THIS PRODUCT 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BBL¿ CULTURESWAB¿ PLUS, THE CUSTOMER EXPERIENCED AN INCREASE POSITIVE YEAST RESULT. UPON RETESTING ONE SAMPLE WITH BOTH A SWAB FROM THE SAME BATCH AND A SWAB FROM A DIFFERENT LOT NUMBER, IT WAS DETERMINED THE BATCH REPORTED PROVIDED A FALSE POSITIVE RESULT. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED. THIS IS REPORT 16 OF 20.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BBL¿ CULTURESWAB¿ PLUS, THE CUSTOMER EXPERIENCED AN INCREASE POSITIVE YEAST RESULT. UPON RETESTING ONE SAMPLE WITH BOTH A SWAB FROM THE SAME BATCH AND A SWAB FROM A DIFFERENT LOT NUMBER, IT WAS DETERMINED THE BATCH REPORTED PROVIDED A FALSE POSITIVE RESULT. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED. THIS IS REPORT 16 OF 20.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311781 BBL¿ CULTURESWAB¿ PLUS CULTURE MEDIA, ANAEROBIC TRANSPORT JSL BECTON DICKINSON & CO. (SPARKS) 241676200 00382902201175

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown