BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD FUSION 3B/3R/6V/5YG ACDU W/HOOD

    MDR report key: 10606080 · Received September 30, 2020

    Report

    Report Number
    2916837-2020-00151
    Event Type
    Malfunction
    Date Received
    September 30, 2020
    Date of Event
    September 9, 2020
    Report Date
    September 30, 2020
    Manufacturer
    BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES
    Product Code
    OYE
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: CHANGE IN REPORTABILITY. THIS COMPLAINT IS NO LONGER REPORTABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE WITH A BD FUSION 3B/3R/6V/5YG ACDU W/HOOD WASTE LEAKAGE OCCURRED OUTSIDE OF INSTRUMENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LEAKING BENEATH THE SHEATH AND WATSE CONTAINERS. UNKNOWN FLUID. 1. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? NO. 2. WAS THE LEAK IN A CUSTOMER ACCESSIBLE LOCATION? YES. 3. WAS THERE SPRAY OF FLUID UNDER PRESSURE? NO. 4. WHAT WAS THE FLUID THAT LEAKED? UNKNOWN. 5. WHAT IS THE SOURCE OF LEAK -- WASTE LINE OR NON-WASTE LINE? UNKNOWN. 6. WAS THE CUSTOMER EXPOSED TO BLOOD OR BODILY FLUIDS? NO. 7. 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 DURING USE WITH A BD FUSION 3B/3R/6V/5YG ACDU W/HOOD WASTE LEAKAGE OCCURRED OUTSIDE OF INSTRUMENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LEAKING BENEATH THE SHEATH AND WATSE CONTAINERS. UNKNOWN FLUID. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? NO. WAS THE LEAK IN A CUSTOMER ACCESSIBLE LOCATION? YES. WAS THERE SPRAY OF FLUID UNDER PRESSURE? NO. WHAT WAS THE FLUID THAT LEAKED? UNKNOWN. WHAT IS THE SOURCE OF LEAK -- WASTE LINE OR NON-WASTE LINE? UNKNOWN. 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
    1068812 BD FUSION 3B/3R/6V/5YG ACDU W/HOOD NA OYE BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other