BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIRST PICC

    MDR report key: 2494378 · Received March 9, 2012

    Report

    Report Number
    1625425-2012-00027
    Event Type
    Malfunction
    Date Received
    March 9, 2012
    Date of Event
    January 23, 2012
    Report Date
    February 9, 2012
    Manufacturer
    ARGON MEDICAL DEVICES INC.
    Product Code
    FOZ
    PMA / PMN Number
    K944504
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS OF THE DEVICE EVAL WILL BE FILED IN A SUPPLEMENTAL REPORT WHEN SAMPLE IS RECEIVED.

    Description of Event or Problem · 1

    THE CATHETER ON THE (B)(6) SECTIONED DURING THE NIGHT OF (B)(6) 2012. THE SAME PROBLEM OCCURRED THE NIGHT OF THE (B)(6) 2012, WHILE CHANGING THE CHILD.

    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 1 MO