BEUDAMED
    FDA Adverse Event Injury Summary report: N

    L-CATH MIDLINE

    MDR report key: 220475 · Received April 21, 1999

    Report

    Report Number
    MW1016183
    Event Type
    Injury
    Date Received
    April 21, 1999
    Date of Event
    April 19, 1999
    Report Date
    April 21, 1999
    Manufacturer
    LUTHER MEDICAL PRODUCTS, INC.
    Product Code
    DQO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE L-CATH POLYURETHANE MIDLINE CATHETER WAS PLACED IN THE RIGHT BASILIC VEIN ON 4/19/99. RESIDENT PULLED ON CATHETER AND CONNECTING TUBING; WHEN SHE PULLED, THE CATHETER BROKE ABOVE THE HUB. CATHETER WAS RETRIEVED OUT OF VEIN, NO PT HARM. THE LOT NUMBER IS ONLY ON THE CARTON, WHICH HOLDS 10 KITS. THE CARTON WAS THROWN AWAY. THE BASIC KIT HAS NO LOT NUMBER ON IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 L-CATH MIDLINE MIDLINE POLYURETHANE DQO LUTHER MEDICAL PRODUCTS, INC. PE 20 PIC 20T UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention