BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRINITY STERILE INC

    MDR report key: 2364855 · Received March 8, 2007

    Report

    Report Number
    2364855
    Event Type
    Malfunction
    Date Received
    March 8, 2007
    Date of Event
    January 23, 2007
    Report Date
    March 8, 2007
    Manufacturer
    TRINITY STERILE INC.
    Product Code
    KXF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WIPING RIGHT HAND WITH SOLUTION PROVIDED IN SPONGE. PATIENT ASKED "ARE YOU CUTTING ME?" THE 4 SUPERFICIAL LACERATIONS NOTED ON RIGHT HAND HORIZONTAL, SAME DIRECTION (SIDE TO SIDE). SPONGE WAS USED TO PREP IV SITE. MILD BRIGHT RED BLOOD NOTED FROM EACH OPEN AREA. RIGHT HAND CLEANSED, BANDAGE APPLIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRINITY STERILE INC IV START KIT W/CHLORAPREP FREPP APPLICATION KXF TRINITY STERILE INC. 22292

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other