BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD FACSARIA SO

    MDR report key: 11920696 · Received June 2, 2021

    Report

    Report Number
    2916837-2021-00265
    Event Type
    Malfunction
    Date Received
    June 2, 2021
    Date of Event
    May 12, 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
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER FURTHER REVIEW MFR#2916837-2021-00265 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 WHILE USING BD FACSARIA¿ SO BIOHAZARDOUS WASTES LEAKED OUTSIDE OF INSTRUMENT. THERE WAS NO USER IMPACT. IT WAS REPORTED BY THE CUSTOMER THAT THE DRAIN CUP OFF OF THE SAMPLE HOLDER IS NOT FULLY DRAINING. 1) WAS THE LEAK LIQUID OR AIR? LIQUID 2) WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? NOT CONTAINED 3) WAS THERE SPRAY OF LIQUID UNDER PRESSURE? NO 4) WHAT WAS THE FLUID THAT LEAKED? BIOHAZARD 5) DID BIOHAZARD LEAK BEFORE OR AFTER WASTE LINE? BEFORE WASTE LINE 6) WAS THE WASTE MIXED WITH DECONTAMINATION/BLEACH? NO 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 THAT WHILE USING BD FACSARIA¿ SO BIOHAZARDOUS WASTES LEAKED OUTSIDE OF INSTRUMENT. THERE WAS NO USER IMPACT. IT WAS REPORTED BY THE CUSTOMER THAT THE DRAIN CUP OFF OF THE SAMPLE HOLDER IS NOT FULLY DRAINING. WAS THE LEAK LIQUID OR AIR? LIQUID. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? NOT CONTAINED. WAS THERE SPRAY OF LIQUID UNDER PRESSURE? NO. WHAT WAS THE FLUID THAT LEAKED? BIOHAZARD. DID BIOHAZARD LEAK BEFORE OR AFTER WASTE LINE? BEFORE WASTE LINE. WAS THE WASTE MIXED WITH DECONTAMINATION/BLEACH? NO. WAS THE CUSTOMER/BD PERSONNEL PHYSICALLY IN CONTACT WITH THE FLUID? NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    822838 BD FACSARIA SO NA OYE BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES NA

    Patients

    Seq Age Sex Outcome Treatment
    1