BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIRST PICC

    MDR report key: 2441770 · Received February 3, 2012

    Report

    Report Number
    1625425-2012-00005
    Event Type
    Malfunction
    Date Received
    February 3, 2012
    Date of Event
    December 20, 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
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS OF THE DEVICE EVAL WILL BE FILED IN A SUPPLEMENTA REPORT WHEN SAMPLE IS RECEIVED. ADD'L INFO REQUESTED NECESSARY IN DETERMINING REPORTABILITY. REQUESTED: 01/03/2012. RECEIVED: 01/17/2012.

    Description of Event or Problem · 1

    THE CATHETER WAS INSERTED IN SEPTEMBER AND ON THE (B)(6), THE TUBE NEAR THE DISC WAS BROKEN AND LEAKAGED. THE NURSE'S STABILIZATION WAS RIGHT.

    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