BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD FACS¿ LYSE WASH ASSISTANT

    MDR report key: 15583242 · Received October 11, 2022

    Report

    Report Number
    2916837-2022-00294
    Event Type
    Malfunction
    Date Received
    October 11, 2022
    Date of Event
    September 29, 2022
    Report Date
    October 5, 2022
    Manufacturer
    BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES
    Product Code
    JQW
    UDI-DI
    00382903371464
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 THE BD FACS¿ LYSE WASH ASSISTANT THAT THE CUSTOMER OBSERVED CONTAMINATION OF TUBES IN FOLLOWING TUBES BEING PROCESSED BY THE LWA. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER OBSERVED CONTAMINATION OF TUBES IN FOLLOWING TUBES BEING PROCESSED BY THE LWA. HE PERFORMED SEVERAL TESTS IN ORDER TO CALCULATE THE CARRYOVER PERCENTAGE, AND THIS CARRYOVER SEEMS TO BE HIGHER THAN THE MAXIMUM CARRYOVER THAT IS SPECIFIED IN THE TECHNICAL SPECIFICATIONS OF THE INSTRUMENT. AS THERE ANY ALLEGED INJURY OR HARM TO USER OR PATIENT? NO. SERIOUS INJURY, NO. ERRONEOUS RESULTS, POTENTIALLY YES. COURSE OF TREATMENT CHANGED, NO. EXPOSURE TO BLOOD/BODILY FLUID NO. SAFETY ISSUE INCL. NEEDLE STICK, MEDICAL INTERVENTION, NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2483292 BD FACS¿ LYSE WASH ASSISTANT STATION, PIPETTING DILUTING CLINICAL USE JQW BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES 337146 00382903371464

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown