BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIRST PICC

    MDR report key: 2423438 · Received January 13, 2012

    Report

    Report Number
    1625425-2011-00158
    Event Type
    Malfunction
    Date Received
    January 13, 2012
    Date of Event
    March 16, 2011
    Report Date
    January 9, 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

    RESULTS OF INVESTIGATION WILL BE FILED IN SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    PATIENT TOOK RIGHT MEDIAN VEIN CATHETER AND PUNCTURE AFTER LEFT BREAST SURGERY IN (B)(6), 2011. CHEMOTHERAPY ONE PERIOD OF TREATMENT WITHOUT ANY BAD REACTION. (B)(6), TO DO SECOND CHEMOTHERAPY, CONVENTIONAL INFUSION, AND AFTER THE COMPLETION OF SEALING PIPE FLUID LEAKAGE WAS FOUND.

    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 56 YR