BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD FACSARIA SO

    MDR report key: 11386241 · Received February 26, 2021

    Report

    Report Number
    2916837-2021-00063
    Event Type
    Malfunction
    Date Received
    February 26, 2021
    Date of Event
    February 8, 2021
    Report Date
    July 30, 2021
    Manufacturer
    BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES
    Product Code
    GKZ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.10 AFTER FURTHER REVIEW MFR#:2916837-2021-00063 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 FACSARIA¿ SO BIOHAZARDOUS WASTE LEAKED OUTSIDE OF INSTRUMENT. THERE WAS NO REPORT OF USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THERE IS A BADLY LEAKING WASTE LINE. 1. WAS THE LEAK LIQUID OR AIR? LIQUID. 2. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? NOT CONTAINED. 3. (IF NOT CONTAINED) WAS THERE SPRAY OF FLUID UNDER PRESSURE? NO. 4. WHAT WAS THE FLUID THAT LEAKED? BIOHAZARD. 5. WHAT IS THE SOURCE OF LEAK ¿ BEFORE WASTE LINE OR AFTER WASTE LINE? AFTER WASTE LINE -5B (IF WASTE LINE) ¿ WAS WASTE MIXED WITH BLEACH OR DECONTAMINATE? NO. 6. WAS THE CUSTOMER/BD PERSONNEL PHYSICALLY IN CONTACT WITH THE FLUID? NO. 7. WHERE DID THE PHYSICAL CONTACT OF FLUID OCCUR? CLEANED UP WITH MY HANDS AND PAPER TOWELS. 8. WHAT PERSONAL PPE WAS BEING USED DURING THE OCCURRENCE? NITRILE GLOVES. 9. WAS THERE ANY IMPACT TO PATIENT SAMPLES DUE TO LEAK? NO. 10. WAS CUSTOMER/BD PERSONNEL HARMED/INJURED? NO.

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED WHILE USING BD FACSARIA" SO BIOHAZARDOUS WASTE LEAKED OUTSIDE OF INSTRUMENT. THERE WAS NO REPORT OF USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THERE IS A BADLY LEAKING WASTE LINE. WAS THE LEAK LIQUID OR AIR? LIQUID. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? NOT CONTAINED. (IF NOT CONTAINED) WAS THERE SPRAY OF FLUID UNDER PRESSURE? NO. WHAT WAS THE FLUID THAT LEAKED? BIOHAZARD. WHAT IS THE SOURCE OF LEAK  BEFORE WASTE LINE OR AFTER WASTE LINE? AFTER WASTE LINE -5B (IF WASTE LINE)  WAS WASTE MIXED WITH BLEACH OR DECONTAMINATE? NO. WAS THE CUSTOMER/BD PERSONNEL PHYSICALLY IN CONTACT WITH THE FLUID? NO. WHERE DID THE PHYSICAL CONTACT OF FLUID OCCUR? CLEANED UP WITH MY HANDS AND PAPER TOWELS. WHAT PERSONAL PPE WAS BEING USED DURING THE OCCURRENCE? NITRILE GLOVES. WAS THERE ANY IMPACT TO PATIENT SAMPLES DUE TO LEAK? NO. WAS CUSTOMER/BD PERSONNEL HARMED/INJURED? NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    285830 BD FACSARIA SO NA GKZ BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES NA

    Patients

    Seq Age Sex Outcome Treatment
    1