BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDICAL ACTION

    MDR report key: 3177074 · Received June 17, 2013

    Report

    Report Number
    3177074
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    June 3, 2013
    Report Date
    June 17, 2013
    Manufacturer
    MEDICAL ACTION INDUSTRIES, INC.
    Product Code
    LRS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    AS THE NURSE WAS APPLYING A TOURNIQUET TO START AN IV, SHE STRETCHED THE TOURNIQUET TO PLACE AND SECURE ON THE ARM. IT SNAPPED IN TWO CAUSING A WELT ON HER FINGER. STAFF SHARED THAT THEY HAVE HAD MULTIPLE OCCURRENCES OF THIS SAME PROBLEM AND FOUND THAT THE SAME IV START KIT HAS ONE TOURNIQUET BUT THAT IT MAY ORIGINATE FROM DIFFERENT COUNTRIES. THE ONE THAT ORIGINATES IN "MY" IS THINNER, BRITTLE AND SNAPS APART EASILY. NURSES HAVE A CONCERN FOR THE POTENTIAL TO INJURE A PATIENT'S FRAGILE SKIN WHEN IT SNAPS APART.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?IV ACCESS.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272918 MEDICAL ACTION KIT, IV START LRS MEDICAL ACTION INDUSTRIES, INC. 267014 163473

    Patients

    Seq Age Sex Outcome Treatment
    1 *