BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIRST PICC

    MDR report key: 2113585 · Received May 24, 2011

    Report

    Report Number
    1625425-2011-00084
    Event Type
    Malfunction
    Date Received
    May 24, 2011
    Date of Event
    February 27, 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

    RESULTS OF INVESTIGATION WILL BE FILED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE TUBE WAS BROKEN UNDER THE OVAL SHAPED JUNCTION. BASED ON ADDITIONAL INFO THAT WAS RECEIVED ON 05/24/2011, THE CATHETER BROKE AFTER INSERTION INTO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FIRST PICC FOZ ARGON MEDICAL DEVICES INC. NA 0174268

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK