BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIRST PICC

    MDR report key: 2113584 · Received May 24, 2011

    Report

    Report Number
    1625425-2011-00083
    Event Type
    Malfunction
    Date Received
    May 24, 2011
    Date of Event
    January 11, 2011
    Report Date
    May 24, 2011
    Manufacturer
    ARGON MEDICAL DEVICES INC.
    Product Code
    FOZ
    PMA / PMN Number
    K944504
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FAILURE COULD NOT BE VERIFIED DUE TO NO PRODUCT BEING RETURNED FOR EVAL. 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 RE-EVALUATED AT THAT TIME.

    Description of Event or Problem · 1

    THERE IS LEAKAGE NEAR THE OVAL SHAPED JUNCTION OF THE CATHETER. THERE WAS NO PT INJURY OR SURGICAL INTERVENTION REQUIRED. BASED ON ADDITIONAL INFO RECEIVED ON 05/24/2011, THE SUBSTANCE THAT WAS LEAKING WAS DRUGS USED FOR INJECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FIRST PICC FOZ ARGON MEDICAL DEVICES INC. NA 0123933

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK