BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTECT IV PLUS SAFETY IV CATHETER - RADIOPAQUE

    MDR report key: 3140857 · Received May 24, 2013

    Report

    Report Number
    MW5030354
    Event Type
    Malfunction
    Date Received
    May 24, 2013
    Date of Event
    May 20, 2013
    Report Date
    May 24, 2013
    Manufacturer
    SMITH MEDICAL ASO, INC
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER CAREGIVERS

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2013, PT ADMISSION TO OUR ED WITH SEIZURES. DURING THE INITIAL ASSESSMENT AND TREATMENT, RN ATTEMPTED TO PLACE AN IV CATHETER INTO THE PT'S RIGHT AC AREA. GOOD BLOOD RETURN BUT NOTED SWELLING IN THE AREA AROUND THE HUB AND REMOVED THE IV CATHETER. THE CATHETER TIP, APPROPRIATELY 1 INCH IN LENGTH WAS MISSING WHEN CATHETER WAS REMOVED FROM THE SITE. RADIOLOGY FILMS WERE TAKEN BUT THE CATHETER TIP LOCATION WAS NOT IDENTIFIED. IV CATHETER WAS RADIOPAQUE. PT WAS TREATED FOR SEIZURES AND ONCE STABILIZED, HE WAS RELEASED WITH INSTRUCTIONS TO RETURN TO ED THE NEXT DAY FOR FOLLOW UP ON FOREIGN BODY. ON (B)(6) 2013, HE WAS...

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231115 PROTECT IV PLUS SAFETY IV CATHETER - RADIOPAQUE NONE FOZ SMITH MEDICAL ASO, INC 3066 JELCO

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR