BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4FX50CM SGL PRO PICC CT-BASIC

    MDR report key: 3190696 · Received June 21, 2013

    Report

    Report Number
    2518902-2013-00030
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    May 8, 2013
    Report Date
    June 20, 2013
    Manufacturer
    MEDCOMP
    Product Code
    LJS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION HAS BEEN INITIATED. WHEN THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    FOUR MONTHS OF CHEMOTHERAPY WITHOUT PROBLEMS. THEN FOUND LEAK AT CATHETER FIXATION, CAUSE NOT CLEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282769 4FX50CM SGL PRO PICC CT-BASIC INFUSION CATHETER-PICC LJS MEDCOMP MR17034101 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention