BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JELCO VIAVALVE

    MDR report key: 12066025 · Received June 25, 2021

    Report

    Report Number
    12066025
    Event Type
    Malfunction
    Date Received
    June 25, 2021
    Date of Event
    June 22, 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

    BABY STUCK 5 TIMES WITH NEW JELCO 24G 5/8" IV CATHETERS IN OPTIMAL LOOKING VEINS BY PERIPHERAL INTRAVENOUS (PIV) PLACEMENT EXPERT RNS. BLOOD RETURN VISUALIZED, TROUBLE ADVANCING CATHETER IN VEIN, WHICH EVENTUALLY BLEW THE VEIN. NEW IV CATHETERS NOT CONDUCIVE FOR EASE OF USE IN BABIES, MAKING THE BABY SUSCEPTIBLE TO MULTIPLE PIV STICKS AND DELAYING TREATMENT AND CARE. GOLDEN HOUR WAS NOT MET, AS PIV ACCESS WAS NOT OBTAINED IN TIME. IV FLUIDS WERE STARTED AT AFTER 1 HOUR AND 30 MINUTES OF ADMISSION. FATHER WAS AT BEDSIDE THE ENTIRE TIME AND WITNESSED THE PROCESS. EDUCATOR MET WITH CLINICAL NURSE SPECIALIST (CNS) AND COMPANY TO DISCUSS ISSUES WITH CATHETERS. JELCO CATHETER. SMITHS MEDICAL JELCO 24G 5/8".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    962278 JELCO VIAVALVE CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS FOZ SMITHS MEDICAL ASD, INC. 3846389

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA