BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIRST PICC

    MDR report key: 2441749 · Received February 3, 2012

    Report

    Report Number
    1625425-2012-00004
    Event Type
    Malfunction
    Date Received
    February 3, 2012
    Date of Event
    December 5, 2011
    Report Date
    January 25, 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 THE DEVICE EVAL WILL BE FILED IN A SUPPLEMENTAL REPORT WHEN SAMPLE IS RECEIVED. ADD'L INFO NECESSARY IN DETERMINING REPORTABILITY. REQUESTED ON 01/03/2012. INFO RECEIVED ON 01/17/2012.

    Description of Event or Problem · 1

    AFTER THE CATHETER HAD BEEN INSERTED FOR ONE MONTH, THE CATHETER WAS FOUND TO BE LEAKING OVER THE DISK. THE CATHETER COULD NOT BE USED ANYMORE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FIRST PICC FOZ ARGON MEDICAL DEVICES INC. NA 1144685

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other