BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LSRFORTESSA X-20 SO

    MDR report key: 10843911 · Received November 16, 2020

    Report

    Report Number
    2916837-2020-00252
    Event Type
    Malfunction
    Date Received
    November 16, 2020
    Date of Event
    August 1, 2020
    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
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER FURTHER REVIEW MFR#2916837-2020-00252 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 LSRFORTESSA X-20 SO WASTE LEAKAGE OCCURRED OUTSIDE OF INSTRUMENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: OUR CLIENT HAD ONE OR TWO INCIDENTS OF A WASTE CONTAINER (OR ITS CONNECTIONS) LEAKING THIS SUMMER. ACCORDING TO HER, IT WAS A PROBLEM WITH A WASTE CONTAINER THAT HAD NOT BEEN EMPTIED. THE PROBLEM HAS SINCE BEEN RESOLVED BY THE CUSTOMER: WASTE CONTAINER EMPTIED AND CONNECTOR VERIFICATION. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? NO. WAS THE LEAK MIXED WITH BLEACH OR DECONTAMINATE? NO. 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.

    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 LSRFORTESSA X-20 SO WASTE LEAKAGE OCCURRED OUTSIDE OF INSTRUMENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: OUR CLIENT HAD ONE OR TWO INCIDENTS OF A WASTE CONTAINER (OR ITS CONNECTIONS) LEAKING THIS SUMMER. ACCORDING TO HER, IT WAS A PROBLEM WITH A WASTE CONTAINER THAT HAD NOT BEEN EMPTIED. THE PROBLEM HAS SINCE BEEN RESOLVED BY THE CUSTOMER: WASTE CONTAINER EMPTIED AND CONNECTOR VERIFICATION. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? NO. WAS THE LEAK MIXED WITH BLEACH OR DECONTAMINATE? NO. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1314425 BD LSRFORTESSA X-20 SO NA OYE BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES NA

    Patients

    Seq Age Sex Outcome Treatment
    1