BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNSPECIFIED BD SMARTSITE EXTENSION SET

    MDR report key: 17187657 · Received June 22, 2023

    Report

    Report Number
    2243072-2023-01093
    Event Type
    Malfunction
    Date Received
    June 22, 2023
    Date of Event
    May 30, 2023
    Report Date
    May 31, 2023
    Manufacturer
    BECTON DICKINSON
    Product Code
    FPA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. THEREFORE, BD CORPORATE HEADQUARTERS IN FRANKLIN LAKES, NJ HAS BEEN LISTED IN SECTIONS D.3. AND G.1. AND THE FRANKLIN LAKES FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. D.4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H.4. DEVICE MANUFACTURE DATE: UNKNOWN. B.3. DATE OF EVENT IS UNKNOWN; AWARENESS DATE HAS BEEN USED FOR THIS FIELD. H.6. INVESTIGATION SUMMARY: NO SAMPLES WERE RECEIVED FOR INVESTIGATION OF COMPLAINT REFERENCE PR 8081378 REPORTED VIA POST MARKET SURVEY; HOWEVER THE CUSTOMER SUGGESTED THAT LEAKAGE WAS DETECTED DURING USE OF A SMARTSITE SECONDARY INFUSION SET. NO FURTHER INFORMATION WAS AVAILABLE TO ASSIST THE INVESTIGATION IN THIS INSTANCE. IN THIS INSTANCE A LOT NUMBER WAS NOT AVAILABLE AND THEREFORE IT IS NOT POSSIBLE TO PERFORM A REVIEW OF THE PRODUCTION DOCUMENTATION FOR THIS PARTICULAR PRODUCT. THE ROOT CAUSE OF THE CUSTOMER¿S EXPERIENCE COULD NOT BE DETERMINED AS THE SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION. IN THIS INSTANCE, WITHOUT A SAMPLE, IT IS NOT POSSIBLE TO DETERMINE WHETHER A MANUFACTURING DEFECT COULD HAVE CAUSED OR CONTRIBUTED TO THE CUSTOMER¿S EXPERIENCE. IN THIS INSTANCE, WITHOUT THE COMPLAINT SAMPLE OR ADDITIONAL INFORMATION ABOUT THE EXACT NATURE OF THE DEFECT IT IS NOT POSSIBLE TO CONCLUSIVELY LINK THIS FEEDBACK TO A SPECIFIC FAILURE MODE. H3 OTHER TEXT SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING UNSPECIFIED BD SMARTSITE EXTENSION SET LEAKAGE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT CLINICIAN AND/OR ANY OF YOUR PATIENTS ENCOUNTERED LEAKAGE WHEN USING THE BD SMARTSITE¿ SECONDARY SET WITHOUT INLINE 0.2 FILTER / LIGHT RESISTANCE IN THE LAST 2 WEEKS. VERBATIM: CLINICIAN EXPERIENCED: LEAKAGE: SODIUM CHLORIDE. DID NOT LEAD TO HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    854421 UNSPECIFIED BD SMARTSITE EXTENSION SET INTRAVASCULAR ADMINISTRATION SET FPA BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown