BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD FACSLYRIC¿

    MDR report key: 18961579 · Received March 22, 2024

    Report

    Report Number
    2916837-2024-00025
    Event Type
    Malfunction
    Date Received
    March 22, 2024
    Date of Event
    February 23, 2024
    Report Date
    March 26, 2024
    Manufacturer
    BECTON DICKINSON AND COMPANY BD BIOSCIENCES
    Product Code
    OYE
    UDI-DI
    00382906628787
    PMA / PMN Number
    SEE H.10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G.5. PMA / 510(K)#: BK230835, K170974, K201814. H.6. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BASED ON THE REVIEW OF COMPLAINT TREND, DEFECT TREND, DHR, RISK ANALYSIS AND SERVICE MAX ACTIVITY, THE COMPLAINT WAS CONFIRMED AND THE POTENTIAL CAUSE OF THE CUSTOMER EXPERIENCING CARRYOVER ISSUES ON THE FACSLYRIC WAS DETERMINED TO BE PINCHED TUBING IN VALVE. FSE PERFORMED TROUBLESHOOTING MEASURES AND THEN ADJUSTED THE MEMORY OF THE TUBING. AFTERWARDS, THE INSTRUMENT IS FUNCTIONING AS EXPECTED. NO ONE WAS HARMED OR INJURED, AND NO MEDICAL DIAGNOSIS WAS PERFORMED DUE TO ANY INCORRECT RESULTS. THE SAFETY RISK OF THIS HAZARD HAS BEEN IDENTIFIED TO BE WITHIN THE ACCEPTABLE LEVEL. COMPLAINTS RECEIVED FOR THIS DEVICE WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED TO DETERMINE IF FURTHER ACTION IS NEEDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD FACSLYRIC¿ FLOW CYTOMETER, CONTAMINATION OF A PATIENT SAMPLE OCCURRED. THERE WAS NO REPORT OF USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED BY CUSTOMER THAT CROSS CONTAMINATION ISSUE. 1.WERE SAMPLES CONTAMINATED? YES. PATIENT SAMPLES CHECKLIST: 1. ARE THERE ERRONEOUS RESULTS ON PATIENT SAMPLES FROM DIAGNOSTIC TEST? (IF YES OR UNKNOWN, GO TO QUESTION #2. IF NO, NO FURTHER QUESTIONS REQUIRED.): NO".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD FACSLYRIC¿ FLOW CYTOMETER, CONTAMINATION OF A PATIENT SAMPLE OCCURRED. THERE WAS NO REPORT OF USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED BY CUSTOMER THAT CROSS CONTAMINATION ISSUE. WERE SAMPLES CONTAMINATED? YES. PATIENT SAMPLES CHECKLIST: ARE THERE ERRONEOUS RESULTS ON PATIENT SAMPLES FROM DIAGNOSTIC TEST? (IF YES OR UNKNOWN, GO TO QUESTION #2. IF NO, NO FURTHER QUESTIONS REQUIRED.): NO".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1756532 BD FACSLYRIC¿ FLOW CYTOMETRIC REAGENTS AND ACCESS OYE BECTON DICKINSON AND COMPANY BD BIOSCIENCES 00382906628787

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown