BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5F DUAL VASCU-PICC

    MDR report key: 4142704 · Received October 2, 2014

    Report

    Report Number
    2518902-2014-00064
    Event Type
    Injury
    Date Received
    October 2, 2014
    Date of Event
    August 30, 2014
    Report Date
    October 1, 2014
    Manufacturer
    MEDCOMP
    Product Code
    JCY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    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

    STAFF NURSE NOTED SWELLING TO THE EXTREMITY WHERE THE PICC LINE WAS INSERTED. THE PICC LINE WAS REMOVED AND AN ULTRASOUND WAS ORDERED BY THE MD. ULTRASOUND REVEALS THAT THERE IS NO EVIDENCE OF THROMBOSIS IN THE LEFT UPPER EXTREMITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    614845 5F DUAL VASCU-PICC INFUSION CATHETER JCY MEDCOMP MR17015206 MBSX660

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention