BEUDAMED
    FDA Adverse Event Injury Summary report: N

    J & J

    MDR report key: 342579 · Received July 11, 2001

    Report

    Report Number
    342579
    Event Type
    Injury
    Date Received
    July 11, 2001
    Date of Event
    June 28, 2001
    Report Date
    June 28, 2001
    Manufacturer
    UNK
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    INSERTED IV INTO RACU AND RECEIVED A FLASH OF BLOOD. TRIED TO ADVANCE THE CATHETER BUT IT WAS ONLY ADVANCED A LITTLE BIT. AFTER PUTTING THE T-CONNECTOR ON THE IV. TRIED TO FLUSH IT WITH SALINE, BUT NOTICED ARM PUFFING UP. SO STARTED TO TAKE THE IV OUT AND WHEN DOING SO, IT SNAPPED OFF LEAVING A PIECE INSIDE THE PT. REQUIRED SURGICAL REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31509 J & J PROTECT IV FOZ UNK 3050 3050

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization| R