BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIRST PICC

    MDR report key: 1935423 · Received November 11, 2010

    Report

    Report Number
    1625425-2010-00020
    Event Type
    Malfunction
    Date Received
    November 11, 2010
    Date of Event
    October 22, 2010
    Report Date
    October 25, 2010
    Manufacturer
    ARGON MEDICAL DEVICES INC.
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CATHETER WAS CUT DURING USE (1 WEEK AFTER INSERTION). THE CATHETER WAS REMOVED BY OPERATION. NO HARM TO THE PT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention