BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JELCO 22G 1"

    MDR report key: 267995 · Received March 6, 2000

    Report

    Report Number
    267995
    Event Type
    Injury
    Date Received
    March 6, 2000
    Date of Event
    February 28, 2000
    Report Date
    March 6, 2000
    Manufacturer
    J & J MEDICAL INC.
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS NOTED THAT THE PREVIOUS IV SITE WAS INFILTRATED. THE NURSE REMOVED THE CATHETER. THE PT WAS A HARD STICK AND MD ORDERED TO PERFORM IV INSERTION IN THE LOWER EXTREMITY. SEVERAL ATTEMPTS WERE DONE TO INSERT THE CATHETER IN THE LEG. ANOTHER NURSE ATTEMPTED TWICE AND NOTICED A SMALL PIECE OF THE TIP OF THE CATHETER IS MISSING (APPROX 3-7MM). THE NURSE WAS TRYING TO THREAD IN THE CATHETER ALONE BUT IT ONLY GO HALFWAY IN AND TRIED TO PUT THE NEEDLE BACK INTO THE CATHETER WITH RESISTANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JELCO 22G 1" IV CATHETER (RADIOPAQUE FEP POLYMER) FOZ J & J MEDICAL INC. 4050 3439K56

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Life Threatening