BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FIRST PICC

    MDR report key: 2553570 · Received April 20, 2012

    Report

    Report Number
    1625425-2012-00036
    Event Type
    Injury
    Date Received
    April 20, 2012
    Report Date
    April 13, 2012
    Manufacturer
    ARGON MEDICAL DEVICES, INC.
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS OF A SAMPLE EVAL WILL BE FILED IN A SUPPLEMENTAL REPORT WHEN COMPLETED.

    Description of Event or Problem · 1

    THE PICC BROKE OFF IN AN INFANT. THE PICC HAD TO BE SURGICALLY REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FIRST PICC FOZ ARGON MEDICAL DEVICES, INC. NA 1038745

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other