BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD FACSCELESTA FLOW CYTOMETER

    MDR report key: 11733608 · Received April 27, 2021

    Report

    Report Number
    2916837-2021-00203
    Event Type
    Malfunction
    Date Received
    April 27, 2021
    Date of Event
    April 2, 2021
    Report Date
    June 17, 2021
    Manufacturer
    BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES
    Product Code
    OYE
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER FURTHER REVIEW MFR#2916837-2021-00203 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 WHILE USING BD FACSCELESTA¿ FLOW CYTOMETER BIOHAZARDOUS WASTE LEAKED OUTSIDE OF INSTRUMENT. THERE WAS NO USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE FFSS' WASTE CONTAINER OVERFLOWED. 1. WAS THE LEAK FLUID OR AIR? LIQUID 2. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? NOT CONTAINED 3. WAS THERE SPRAY OF FLUID UNDER PRESSURE? NO 4. WHAT WAS THE FLUID THAT* LEAKED? BIOHAZARD 5. DID BIOHAZARD LEAK BEFORE OR AFTER WASTE LINE? AFTER WASTE LINE 6. WAS THE WASTE MIXED WITH DECONTAMINATION OR BLEACH? NO 7. WAS THE CUSTOMER/BD PERSONNEL PHYSICALLY IN CONTACT WITH THE FLUID? PHYSICAL CONTACT INCLUDES: CLOTHING, SKIN, MUCOUS MEMBRANE (E.G. INHALATION), AND NON-INTACT SKIN." NO 8. WHICH PART OF THE BODY WAS IN CONTACT TO THE FLUID? 9. WHAT PERSONAL PROTECTIVE EQUIPMENT (PPE) WAS BEING WORN? 10. WAS THERE ANY IMPACT TO PATIENT SAMPLES DUE TO LEAK? ) 11. WAS CUSTOMER HARMED/INJURED? 12. WHAT IS THE CURRENT MEDICAL STATUS?

    Additional Manufacturer Narrative · 1

    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 · 1

    IT WAS REPORTED WHILE USING BD FACSCELESTA" FLOW CYTOMETER BIOHAZARDOUS WASTE LEAKED OUTSIDE OF INSTRUMENT. THERE WAS NO USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE FFSS' WASTE CONTAINER OVERFLOWED. WAS THE LEAK FLUID OR AIR? LIQUID. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? NOT CONTAINED. WAS THERE SPRAY OF FLUID UNDER PRESSURE? NO. WHAT WAS THE FLUID THAT* LEAKED? BIOHAZARD. DID BIOHAZARD LEAK BEFORE OR AFTER WASTE LINE? AFTER WASTE LINE. WAS THE WASTE MIXED WITH DECONTAMINATION OR BLEACH? NO. WAS THE CUSTOMER/BD PERSONNEL PHYSICALLY IN CONTACT WITH THE FLUID? PHYSICAL CONTACT .INCLUDES: CLOTHING, SKIN, MUCOUS MEMBRANE (E.G. INHALATION), AND NON-INTACT SKIN." NO WHICH PART OF THE BODY WAS IN CONTACT TO THE FLUID? WHAT PERSONAL PROTECTIVE EQUIPMENT (PPE) WAS BEING WORN? WAS THERE ANY IMPACT TO PATIENT SAMPLES DUE TO LEAK? ) WAS CUSTOMER HARMED/INJURED? WHAT IS THE CURRENT MEDICAL STATUS?

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631898 BD FACSCELESTA FLOW CYTOMETER NA OYE BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES NA

    Patients

    Seq Age Sex Outcome Treatment
    1