BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD FACSLYRIC¿

    MDR report key: 23089541 · Received September 18, 2025

    Report

    Report Number
    3027394506-2025-00040
    Event Type
    Malfunction
    Date Received
    September 18, 2025
    Date of Event
    September 4, 2025
    Report Date
    October 31, 2025
    Manufacturer
    BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES
    Product Code
    OYE
    UDI-DI
    00382906628756
    PMA / PMN Number
    BK230835
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E.1- INITIAL REPORTER E-MAIL: (B)(6). E.2- INITIAL REPORTER ADDR 1: (B)(6). G.1- PMA / 510(K)#: K170974; K201814. H.3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: BASED ON THE INVESTIGATION RESULTS, THE CAUSE OF THE COMPLAINT WAS CONFIRMED TO BE DUE TO DIRTY SIT FLUSH TUBING. THE CUSTOMER HAD REPORTED THAT THE INSTRUMENT WAS EXHIBITING CARRYOVER BETWEEN SAMPLES, AND A FIELD SERVICE ENGINEER (FSE) WAS SENT ONSITE TO INVESTIGATE THE ISSUE. THE FSE CONFIRMED THE ISSUE AND PROCEEDED TO CLEAN THE SIT FLUSH TUBING, RESEAT THE PINCH VALVE, AND CHANGED THE ASSAY SIT FLUSHES FROM 1 TO 3. THE INSTRUMENT WAS THEN FUNCTIONING AS EXPECTED AND WAS RETURNED TO THE CUSTOMER. THERE WAS NO IMPACT TO PATIENT DIAGNOSIS OR TREATMENT. A RETURN SAMPLE WAS NOT REQUESTED FOR EVALUATION AS THE ROOT CAUSE OF THE ISSUE WAS IDENTIFIED WITHOUT REQUIRING A SAMPLE ANALYSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USAGE OF BD FACSLYRIC¿ CARRYOVER BETWEEN PATIENT SAMPLES WAS OBSERVED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT THERE WAS CARRY OVER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USAGE OF BD FACSLYRIC¿ CARRYOVER BETWEEN PATIENT SAMPLES WAS OBSERVED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT THERE WAS CARRY OVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2831158 BD FACSLYRIC¿ FLOW CYTOMETRIC REAGENTS AND ACCESSORIES OYE BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES 00382906628756

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown