BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD FACSMELODY

    MDR report key: 11204840 · Received January 20, 2021

    Report

    Report Number
    2916837-2021-00031
    Event Type
    Malfunction
    Date Received
    January 20, 2021
    Date of Event
    December 28, 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
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER FURTHER REVIEW MFR#2916837-2021-00031 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 FACSMELODY¿ WASTE LEAKED OUTSIDE OF INSTRUMENT. THERE WAS NO REPORT OF USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LEAK ON THE FLOOR. 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? BEFORE WASTE LINE -5B (IF WASTE LINE). ¿ WAS WASTE MIXED WITH BLEACH OR DECONTAMINATE? N/A. WAS THE CUSTOMER/BD PERSONNEL PHYSICALLY IN CONTACT WITH THE FLUID? NO. WHERE DID THE PHYSICAL CONTACT OF FLUID OCCUR? N/A. WHAT PERSONAL PPE WAS BEING USED DURING THE OCCURRENCE? GLOVES, LAB COAT, EYE PROTECTION. WAS THERE ANY IMPACT TO PATIENT SAMPLES DUE TO LEAK? NO. WAS CUSTOMER/BD PERSONNEL HARMED/INJURED? 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING BD FACSMELODY¿ WASTE LEAKED OUTSIDE OF INSTRUMENT. THERE WAS NO REPORT OF USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LEAK ON THE FLOOR. 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? BEFORE WASTE LINE. (IF WASTE LINE) ¿ WAS WASTE MIXED WITH BLEACH OR DECONTAMINATE? N/A. WAS THE CUSTOMER/BD PERSONNEL PHYSICALLY IN CONTACT WITH THE FLUID? NO. WHERE DID THE PHYSICAL CONTACT OF FLUID OCCUR? N/A. WHAT PERSONAL PPE WAS BEING USED DURING THE OCCURRENCE? GLOVES, LAB COAT, EYE PROTECTION. 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
    102247 BD FACSMELODY NA OYE BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES NA

    Patients

    Seq Age Sex Outcome Treatment
    1