BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD UNSPECIFIED IV PIGGYBACK SECONDARY SET

    MDR report key: 17932021 · Received October 13, 2023

    Report

    Report Number
    2243072-2023-01853
    Event Type
    Malfunction
    Date Received
    October 13, 2023
    Date of Event
    September 21, 2023
    Report Date
    September 21, 2023
    Manufacturer
    BECTON DICKINSON
    Product Code
    FPA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    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 8940123 REPORTED VIA POST MARKET SURVEY; HOWEVER THE CUSTOMER SUGGESTED THAT LEAKAGE WAS DETECTED FROM A SECONDARY INFUSION SET DURING INFUSION. 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 BD / CAREFUSION SECONDARY SET (IV PIGGYBACK SET) LEAKAGE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. IT WAS REPORTED THAT CLINICIAN AND/OR ANY OF YOUR PATIENTS ENCOUNTERED LEAKAGE ISSUES WHEN USING THE BD / CAREFUSION SECONDARY SET (IV PIGGYBACK SET) IN THE LAST 2 WEEKS. VERBATIM: CLINICIAN EXPERIENCED: YES, I DID ENCOUNTER LEAKAGE WITH THE LAST BD / CAREFUSION SECONDARY SET (IV PIGGYBACK SET) I USED IN THIS PATIENT (FREE LIQUID).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1552539 BD UNSPECIFIED IV PIGGYBACK SECONDARY SET INTRAVASCULAR ADMINISTRATION SET FPA BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown