BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIRST PICC

    MDR report key: 1934526 · Received November 23, 2010

    Report

    Report Number
    1625425-2010-00025
    Event Type
    Malfunction
    Date Received
    November 23, 2010
    Date of Event
    October 24, 2010
    Report Date
    November 19, 2010
    Manufacturer
    ARGON MEDICAL DEVICES INC.
    Product Code
    LJS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS OF DEVICE INVESTIGATION WILL BE FILED IN A SUPPLEMENTAL REPORT WHEN COMPLETED.

    Description of Event or Problem · 1

    THE NURSE FOUND LEAKAGE FROM THE CATHETER NEAR OVAL DISK DURING INFUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FIRST PICC FIRST PICC LJS ARGON MEDICAL DEVICES INC. NA 0104414

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR CHEMOTHERAPY DRUGS