BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIRST PICC KIT W/ INTROSYTE-N INTRODUCER

    MDR report key: 2030830 · Received March 22, 2011

    Report

    Report Number
    1625425-2011-00033
    Event Type
    Malfunction
    Date Received
    March 22, 2011
    Date of Event
    February 22, 2011
    Report Date
    March 22, 2011
    Manufacturer
    ARGON MEDICAL DEVICES INC.
    Product Code
    LJS
    PMA / PMN Number
    K945499
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS OF INVESTIGATION WILL BE FILED IN A SUPPLEMENTAL REPORT ONCE SAMPLE HAS BEEN EVALUATED.

    Description of Event or Problem · 1

    CATHETER HAD BROKEN OFF IN THE PT AFTER A FEW DAYS (BROKEN). BROKEN AT THE SECUREMENT TAB. NO BLOOD LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FIRST PICC KIT W/ INTROSYTE-N INTRODUCER LJS ARGON MEDICAL DEVICES INC. NA 0299862

    Patients

    Seq Age Sex Outcome Treatment
    1 1 MO Other