BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LSRFORTESSA X-20

    MDR report key: 11164342 · Received January 13, 2021

    Report

    Report Number
    2916837-2021-00017
    Event Type
    Malfunction
    Date Received
    January 13, 2021
    Date of Event
    December 18, 2020
    Report Date
    June 12, 2021
    Manufacturer
    BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES
    Product Code
    OYE
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER FURTHER REVIEW MFR# 2916837-2021-00017 IS NO LONGER REPORTABLE. THIS DEVICE IS FOR RESEARCH USE ONLY AND IS NOT BEING USED FOR DIAGNOSTIC TESTING OR PATIENT TREATMENT AND IS THEREFORE NOT SUBJECT TO MDR REPORTING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WASTE LEAKAGE WITHOUT BLEACH WAS NOT CONTAINED (OUTSIDE INSTRUMENT) WHILE USING THE BD LSRFORTESSA¿ X-20. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE INSTRUMENT'S LASER DELAYS ARE INCORRECT, ONLY BLUE LASER SIGNAL CAN BE FOUND. OVERFLOW FROM THE WASTE CONTAINER. 1. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? NOT CONTAINED. 2. WAS THE LEAK IN A CUSTOMER ACCESSIBLE LOCATION? NO. 3. WHAT WAS THE FLUID THAT LEAKED? BIOHAZARD. 4. WHAT IS THE SOURCE OF LEAK -- WASTE LINE OR NON-WASTE LINE? AFTER WASTE LINE. 5. WAS THE CUSTOMER EXPOSED TO BLOOD OR BODILY FLUIDS? NO. 6. WAS THERE ANY PHYSICAL HARM TO THE CUSTOMER AS A RESULT OF THE LEAK? NO.¿

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER PHONE NUMBER: (B)(6). MEDICAL DEVICE EXPIRATION DATE: NA A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WASTE LEAKAGE WITHOUT BLEACH WAS NOT CONTAINED (OUTSIDE INSTRUMENT) WHILE USING THE BD LSRFORTESSA" X-20. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE INSTRUMENT'S LASER DELAYS ARE INCORRECT, ONLY BLUE LASER SIGNAL CAN BE FOUND. OVERFLOW FROM THE WASTE CONTAINER. 1. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? NOT CONTAINED 2. WAS THE LEAK IN A CUSTOMER ACCESSIBLE LOCATION? NO 3. WHAT WAS THE FLUID THAT LEAKED? BIOHAZARD 4. WHAT IS THE SOURCE OF LEAK -- WASTE LINE OR NON-WASTE LINE? AFTER WASTE LINE 5. WAS THE CUSTOMER EXPOSED TO BLOOD OR BODILY FLUIDS? NO 6. WAS THERE ANY PHYSICAL HARM TO THE CUSTOMER AS A RESULT OF THE LEAK? NO

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64654 BD LSRFORTESSA X-20 NA OYE BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES NA

    Patients

    Seq Age Sex Outcome Treatment
    1