BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JELCO

    MDR report key: 7486422 · Received May 4, 2018

    Report

    Report Number
    7486422
    Event Type
    Malfunction
    Date Received
    May 4, 2018
    Date of Event
    January 12, 2018
    Report Date
    April 27, 2018
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PRIOR TO IV DISCONNECTION, IV SITE DRESSING WAS PEELED OFF AT UPPER RIGHT CORNER AND CATHETER 3/4 OUT, IV SITE WAS ASSESSED THIS MORNING, TEGADERM WAS INTACT, AND CATHETER INSERTED COMPLETED. IV WAS DISCONTINUED AND TIP WAS NOT INTACT, PALPATED ARM, NO SWELLING OR BLEEDING NOTED. NO RETAINED FOREIGN BODY WAS FOUND AND PT WAS DISCHARGED. MEDICAL DOCTOR AWARE. SMITHS MEDICAL JELCO 18GX1 1/4" PROTECTIVE IV PLUS SAFETY IV CATHETER RADIOPAQUE SMITHS MEDICAL ASD, INC. LOT # 3529386.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329621 JELCO CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS FOZ SMITHS MEDICAL ASD, INC. 3529386

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR