BEUDAMED
    FDA Adverse Event Injury Summary report: N

    L-CATH PEEL AWAY PICC

    MDR report key: 31941 · Received April 10, 1996

    Report

    Report Number
    MW1008849
    Event Type
    Injury
    Date Received
    April 10, 1996
    Date of Event
    April 9, 1996
    Report Date
    April 9, 1996
    Manufacturer
    LUTHER MEDICAL PRODUCTS, INC.
    Product Code
    DQO
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT PRESENTED TO PHARMACY ON 4/9/96, WITH C/O LEFT ARM BEING SWOLLEN AND HAVING A COLOR CHANGE. A SINGLE LUMEN CATHETER WAS INSERTED INTO THE CEPHALIC VEIN ON 3/22/96. ULTRASOUND OF ARM ACCOMPLISHED ON 4/9/96, CLOT FOUND IN ARM, ORIGINATING AT POINT OF ENTRY UP TO THE SUBCALVIAN VEIN. CATHETER REMOVED WITH MD ASSISTANCE. PT HOSPITALIZED ON 4/9/95 FOR HEPARIN THERAPY ALSO ON COUMADIN 5 MG/DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 L-CATH PEEL AWAY PICC Implant PERIPHERALLY INSERTED CENTRAL CATHETER DQO LUTHER MEDICAL PRODUCTS, INC. LM P 1598

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization CEFAZOLIN 1 GRAM IV EVERY 8 HRS.