BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD INSYTE AUTOGUARD BC

    MDR report key: 22214658 · Received June 16, 2025

    Report

    Report Number
    2243072-2025-00752
    Event Type
    Injury
    Date Received
    June 16, 2025
    Date of Event
    May 27, 2025
    Report Date
    June 19, 2025
    Manufacturer
    BECTON DICKINSON
    Product Code
    FOZ
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. H.3. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED. IN THIS MDR, BD FRANKLIN LAKES, NJ HAS BEEN LISTED IN SECTIONS D.3. AND G.1. AS THE MANUFACTURING SITE IS UNKNOWN.

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: AS NO PHYSICAL OR PICTURE SAMPLE, OR VALID LOT NUMBER WAS PROVIDED FOR EVALUATION, BY OUR QUALITY ENGINEER TEAM, A COMPLETE INVESTIGATION COULD NOT BE PERFORMED. THERE ARE CURRENT QUALITY CONTROLS IN PLACE TO DETECT THIS TYPE OF PRODUCT MALFUNCTION DURING THE PRODUCTION PROCESS. BASED ON THE LIMITED INVESTIGATION RESULTS, A CAUSE FOR THE REPORTED INCIDENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    THE FOLLOWING REPORTABLE EVENT WAS DERIVED FROM A LITERATURE REVIEW. LONG GUIDEWIRE PERIPHERAL INTRAVENOUS CATHETERS IN EMERGENCY DEPARTMENTS FOR MANAGEMENT OF DIFFICULT INTRAVENOUS ACCESS: A MULTICENTER, PRAGMATIC, RANDOMIZED CONTROLLED TRIAL. HUI (GRACE) XU PHD1,2,3,4 / AMANDA CORLEY PHD3,4,5 / EMILY R. YOUNG MD6 / ANNA DOUBROVSKY MD1 / ROBERT S. WARE PHD6 / CLIFFORD AFOAKWAH PHD7,8 / CARRIE WANG MD2 / SCOTT STIRLING MD9 / NICOLE MARSH PHD3,4,5,6. BACKGROUND: A QUARTER OF PATIENTS WHO PRESENT TO EMERGENCY DEPARTMENTS (EDS) HAVE DIFFICULT INTRAVENOUS ACCESS (DIVA), MAKING IT CHALLENGING FOR CLINICIANS TO SUCCESSFULLY PLACE A PERIPHERAL INTRAVENOUS CATHETER (PIVC). SOME LITERATURE SUGGESTS THAT GUIDEWIRE PIVC IMPROVES FIRST-INSERTION SUCCESS RATE. AIM: THE AIM WAS TO DETERMINE THE CLINICAL AND COST-EFFECTIVENESS OF A NOVEL LONG PIVC (5.8 CM) WITH A RETRACTABLE COILED GUIDEWIRE (GW-PIVC) FOR PATIENTS WITH DIVA, COMPARED WITH STANDARD CARE PIVCS. METHODS: A PRAGMATIC RANDOMIZED CONTROLLED TRIAL WAS CONDUCTED IN TWO AUSTRALIAN EDS. ELIGIBLE PARTICIPANTS WERE ADULTS ASSESSED AS MEETING DIVA CRITERIA. PARTICIPANTS WERE RANDOMIZED (1:1 RATIO; STRATIFIED BY HOSPITAL) TO EITHER GW-PIVC (LONG) OR STANDARD CARE GROUP (SHORT OR LONG PIVC). THE USE OF ULTRASOUND WAS DISCRETIONARY IN THE STANDARD CARE GROUP AND WAS RECOMMENDED IN THE GW-PIVC GROUP DUE TO THE PRAGMATIC DESIGN THAT WAS PRIMARILY TESTING THE GW-PIVC RATHER THAN THE ULTRASOUND USE. PRIMARY OUTCOME WAS FIRST-INSERTION SUCCESS AND SECONDARY OUTCOMES INCLUDED ALL-CAUSE DEVICE FAILURE, PATIENT AND STAFF SATISFACTION, AND COST-EFFECTIVENESS. THE ANALYSIS WAS INTENTION TO TREAT. BD INSYTE AUTOGUARD BC (<4 CM LENGTH). SUSPECTED LOCAL INFECTION 1 (0.5). SERIOUS ADVERSE EVENTS (DEATH) 0 (0.0).

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1442750 BD INSYTE AUTOGUARD BC PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other