BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UTAH MEDICAL

    MDR report key: 2614789 · Received June 7, 2012

    Report

    Report Number
    MW5025735
    Event Type
    Injury
    Date Received
    June 7, 2012
    Date of Event
    April 3, 2012
    Report Date
    May 24, 2012
    Manufacturer
    UTAH MEDICAL
    Product Code
    FOS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    LA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    NO ADVERSE EVENT. UMBILICAL VENOUS LINE CATHETER WAS IN PLACE AT 7CM MARK FROM PLACEMENT PER X-RAY. NNP ATTEMPTING UMBILICAL ARTERIAL CATHETER PLACEMENT. NNP NOTED THAT LINE APPEARED TO BE CUT OR BROKEN. NURSE TOOK SCISSORS AND CUT SUTURE HOLDING LINE TO SKIN WHILE NNP HELD UPPER PART OF THE LINE, NURSE CUT SUTURE FROM SKIN. WHEN NNP PULLED THE UVC, 1-5CM MISSING. MD TO THE UNIT AND USED FLUOROSCOPY, RETRIEVED THE 1-5CM OF UVC LINE. NEW LINE PLACED UNDER STERILE CONDITIONS. BOTH PIECES OF THE BROKEN/CUT LINE SENT TO MFR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UTAH MEDICAL UMBILICAL LINE FOS UTAH MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention