BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIRST PICC

    MDR report key: 2441772 · Received February 3, 2012

    Report

    Report Number
    1625425-2012-00007
    Event Type
    Malfunction
    Date Received
    February 3, 2012
    Date of Event
    September 27, 2011
    Report Date
    January 26, 2012
    Manufacturer
    ARGON MEDICAL DEVICES INC.
    Product Code
    FOZ
    PMA / PMN Number
    K944504
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FAILURE COULD NOT BE VERIFIED DUE TO NO PRODUCT BEING RETURNED FOR EVALUATION. A ROOT CAUSE IS UNABLE TO BE DETERMINED; THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN. IF PRODUCT IS RETURNED IN THE FUTURE, THE ISSUE WILL BE REEVALUATED AT THAT TIME. ADD'L INFO REQUESTED NECESSARY IN DETERMINING REPORTABILITY. REQUESTED: 01/03/2011. RECEIVED: 01/17/2012.

    Description of Event or Problem · 1

    CATHETER BROKE AFTER THREE DAYS INSERTION, WITH NO CERTAIN REASONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FIRST PICC FOZ ARGON MEDICAL DEVICES INC. NA 0146711

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other