BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IV START KIT

    MDR report key: 1286203 · Received January 8, 2009

    Report

    Report Number
    1286203
    Event Type
    Malfunction
    Date Received
    January 8, 2009
    Date of Event
    November 26, 2008
    Report Date
    January 8, 2009
    Manufacturer
    TRINITY STERILE, INC.
    Product Code
    LRS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHILE THE RADIOLOGY TECH WAS WIPING THE PATIENT'S ARM WITH IV START KIT SPONGE, THE PATIENT BEGAN TO BLEED FROM SCRATCHES CAUSED BY A SMALL PIECE OF PLASTIC OR GLASS IN THE SPONGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IV START KIT KIT, IV SITE PREP LRS TRINITY STERILE, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR