BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JELCO VIAVALVE

    MDR report key: 12066001 · Received June 25, 2021

    Report

    Report Number
    12066001
    Event Type
    Malfunction
    Date Received
    June 25, 2021
    Date of Event
    June 23, 2020
    Report Date
    June 18, 2021
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PATIENT REQUIRED IV ACCESS UPON ADMISSION. USING THE NEW SMITHS MEDICAL JELCO VIAVALVE SAFETY IV CATHETERS, IT TOOK FOUR NURSES AND SIX ATTEMPTS TO SUCCESSFULLY OBTAIN IV ACCESS. BECAUSE IT TOOK SO MANY ATTEMPTS, THE GOLDEN HOUR WAS NOT MET AND THERE WAS A DELAY IN STARTING IV FLUIDS AND ADMINISTERING MEDICATIONS. THESE NEW IV CATHETERS ARE EXTREMELY DIFFICULT TO USE, OFTEN REQUIRING TWO SETS OF HANDS TO REMOVE THE CATHETER FROM THE NEEDLE AND ATTACH THE T-CONNECTOR. EVEN IF THE IV CATHETER IS INSERTED INTO THE VEIN CORRECTLY, IT IS DIFFICULT TO KEEP THE CATHETER STABLE ENOUGH TO REMOVE IT FROM THE NEEDLE WITHOUT LOSING ACCESS. LEARNING SPECIALIST MET WITH CNS (CLINICAL NURSE SPECIALIST) AND COMPANY TO DISCUSS ISSUES WITH CURRENT IV CATHETERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    961829 JELCO VIAVALVE CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS FOZ SMITHS MEDICAL ASD, INC. 3941641

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA