BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1.9FX50CM SGL LMN VASCU-PICC

    MDR report key: 2443730 · Received February 3, 2012

    Report

    Report Number
    2518902-2012-00022
    Event Type
    Injury
    Date Received
    February 3, 2012
    Date of Event
    December 30, 2011
    Report Date
    February 2, 2012
    Manufacturer
    MEDCOMP
    Product Code
    LJS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT EXPERIENCED A PLEURAL EFFUSION. INITIAL PICC TIP POSITION IN SVC; EXTERNAL CATHETER MIGRATION WITH TIP POSITION I THE RIGHT SUBCLAVIAN VEIN AT THE TIME THE PLEURAL EFFUSION WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1.9FX50CM SGL LMN VASCU-PICC INFUSION CATHETER, PICC LJS MEDCOMP MR17011101 MBH370

    Patients

    Seq Age Sex Outcome Treatment
    1 2 DA Required Intervention