BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    L CATH INTRODUCER

    MDR report key: 223994 · Received May 14, 1999

    Report

    Report Number
    2022441-1999-00005
    Event Type
    Malfunction
    Date Received
    May 14, 1999
    Date of Event
    April 13, 1999
    Report Date
    May 13, 1999
    Manufacturer
    LUTHER MEDICAL PRODUCTS, INC.
    Product Code
    DYB
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PLASTIC SHEATH IS BRITTLE AND WILL BREAK OR CRUMBLE WHEN ATTEMPTING TO BREAK APART.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 L CATH INTRODUCER CATHETER INTRODUCER DYB LUTHER MEDICAL PRODUCTS, INC. NA LMP 3706

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO