BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHLORAPREP¿ ANTISEPTIC, 1.5ML FREPP APPLICATOR

    MDR report key: 2513092 · Received March 29, 2012

    Report

    Report Number
    2513092
    Event Type
    Malfunction
    Date Received
    March 29, 2012
    Date of Event
    March 28, 2012
    Report Date
    March 29, 2012
    Manufacturer
    MEDICAL ACTION INDUSTRIES, INC.
    Product Code
    LRS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A NURSE WAS USING CHLORAPREP APPLICATOR FROM IV START KIT TO PREPARE SKIN FOR IV INSERTION. THE ANTICUBITAL VEIN WAS SELECTED FOR IV INSERTION. PREP CASE WAS CRACKED OPEN IN THE USUAL FASHION AND SEVERAL SWIPES OF THE ARM WERE DONE. AFTER SWIPING THE ARM, IT WAS NOTED THAT THERE WAS A 4 INCH SUPERFICIAL LACERATION WHERE THE PREP WAS APPLIED. THE AREA WAS CLEANED AND PRESSURE HELD TO STOP BLEEDING. NO SUTURES OR BANDAGE WAS NEEDED. THE NURSE PHOTOGRAPHED ARM FOR DOCUMENTATION PURPOSES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHLORAPREP¿ ANTISEPTIC, 1.5ML FREPP APPLICATOR IV PREP KIT - CHLORAPREP¿ ANTISEPTIC, 1.5ML FREPP APPLICATOR LRS MEDICAL ACTION INDUSTRIES, INC. 56892 132019

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR