BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD FACS LWA

    MDR report key: 11739819 · Received April 28, 2021

    Report

    Report Number
    2916837-2021-00205
    Event Type
    Malfunction
    Date Received
    April 28, 2021
    Date of Event
    April 2, 2021
    Report Date
    April 28, 2021
    Manufacturer
    BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES
    Product Code
    JQW
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    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 FACS" LWA WASTE LEAKED OUTSIDE OF INSTRUMENT. THERE WAS NO USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE WASH BASIN IS OVER FLOWING. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? NO. WAS THE LEAK IN A CUSTOMER ACCESSIBLE LOCATION? YES. WHAT WAS THE FLUID THAT LEAKED? WASTE. WHAT IS THE SOURCE OF LEAK -- WASTE LINE OR NON-WASTE LINE? WASTE LINE. WAS THE CUSTOMER EXPOSED TO BLOOD OR BODILY FLUIDS? NO. WAS THERE ANY PHYSICAL HARM TO THE CUSTOMER AS A RESULT OF THE LEAK? NO. WAS THE FLUID SPRAYING OUT FROM THE POINT OF THE LEAK? NO. WAS THE WASTE MIXED WITH DECONTAMINATION / BLEACH SOLUTION? UNKNOWN. WAS PROPER PPE BEING WORN AT TIME OF LEAK AND DURING CLEAN UP? YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    634172 BD FACS LWA STATION, PIPETTING DILUTING CLINICAL USE JQW BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES NA

    Patients

    Seq Age Sex Outcome Treatment
    1