BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5F DUAL VASCU-PICC

    MDR report key: 4142707 · Received October 2, 2014

    Report

    Report Number
    2518902-2014-00065
    Event Type
    Injury
    Date Received
    October 2, 2014
    Date of Event
    August 23, 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

    THE DEVICE INVOLVED IN THE COMPLAINT WAS NOT RETURNED FOR EVAL. A REVIEW OF THE MFG RECORDS INDICATED ALL DEVICE SPECIFICATIONS AND QUALITY REQUIREMENTS WERE SATISFIED. WITHOUT EVALUATING THE DEVICE INVOLVED IN THE COMPLAINT WE ARE UNABLE TO DETERMINE THE CAUSE OR FACTORS WHICH MAY HAVE CONTRIBUTED TO THIS EVENT. VASCULAR THROMBOSIS AND MECHANICAL PHLEBITIS ARE KNOWN POTENTIAL COMPLICATIONS OF THIS DEVICE AND IS LISTED IN THE INSTRUCTIONS FOR USE.

    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 SEVERE OCCLUSIVE DEEP VENOUS THROMBOSIS WHICH INVOLVES THE LEFT SUBCLAVIAN, AXILLARY AND BRACHIAL VEINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    614295 5F DUAL VASCU-PICC INFUSION CATHETER JCY MEDCOMP MR17015206 MBVH580

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Required Intervention