BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    L CATH PICC KIT

    MDR report key: 4180388 · Received October 6, 2014

    Report

    Report Number
    4180388
    Event Type
    Malfunction
    Date Received
    October 6, 2014
    Date of Event
    January 28, 2013
    Report Date
    October 6, 2014
    Manufacturer
    ARGON MEDICAL DEVICES, INC.
    Product Code
    LJS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IA, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    THE INTRODUCER NEEDLE THAT WAS WITH THE L-CATH PICC KIT WOULD NOT ALLOW THE CATHETER TO BE PASSES THROUGH PRIOR TO INSERTION. NEEDLE WAS CHECKED FOR PASSAGE OF CATHETER BEFORE PROCEDURE BEGAN. NEEDLE WAS DISCARDED AND NEW NEEDLE USED.THIS FACILITY HAS HAD MULTIPLE PROBLEMS WITH THE SPLITTABLE NEEDLE IN THIS KIT. THE MANUFACTURER HAS BEEN NOTIFIED AND PRODUCT HAS BEEN RETURNED. THE CAUSE OF THE PROBLEM REMAINS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    624159 L CATH PICC KIT KIT, INTRAVASCULAR CATHETER, LONG TERM LJS ARGON MEDICAL DEVICES, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *