BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD FACSYMPHONY

    MDR report key: 11798533 · Received May 10, 2021

    Report

    Report Number
    2916837-2021-00229
    Event Type
    Malfunction
    Date Received
    May 10, 2021
    Date of Event
    April 19, 2021
    Report Date
    July 29, 2021
    Manufacturer
    BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES
    Product Code
    OYE
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER FURTHER REVIEW MFR#: 2916837-2021-00229 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 FACSYMPHONY¿ BIO-HAZARDOUS WASTE LEAKED OUTSIDE OF INSTRUMENT. THERE WAS NO PATIENT/USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: DRIPPING FROM SIT. PLEASE CONFIRM THE SAFETY CHECK BELOW. 1. WAS THE LEAK FLUID OR AIR? FLUID. 2. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? NO. 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? BEFORE WASTE LINE. 7. WAS THE CUSTOMER/BD PERSONNEL PHYSICALLY IN CONTACT WITH THE FLUID? NO.

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED WHILE USING BD FACSYMPHONY¿ BIO-HAZARDOUS WASTE LEAKED OUTSIDE OF INSTRUMENT. THERE WAS NO PATIENT/USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: DRIPPING FROM SIT. PLEASE CONFIRM THE SAFETY CHECK BELOW. WAS THE LEAK FLUID OR AIR? FLUID. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? NO. WAS THERE SPRAY OF FLUID UNDER PRESSURE? NO. WHAT WAS THE FLUID THAT LEAKED? BIOHAZARD. DID BIOHAZARD LEAK BEFORE OR AFTER WASTE LINE? BEFORE WASTE LINE. WAS THE CUSTOMER/BD PERSONNEL PHYSICALLY IN CONTACT WITH THE FLUID? NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    699878 BD FACSYMPHONY NA OYE BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES NA

    Patients

    Seq Age Sex Outcome Treatment
    1