BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRO-PICC-MAXIMUM BARRIER KIT

    MDR report key: 8654876 · Received May 29, 2019

    Report

    Report Number
    MW5086987
    Event Type
    Injury
    Date Received
    May 29, 2019
    Date of Event
    January 30, 2019
    Report Date
    May 24, 2019
    Manufacturer
    MEDCOMP (MEDICAL COMPONENTS, INC)
    Product Code
    LJS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    LINE PLACED ON (B)(6) 2019, LATER NOTED TO BE LEAKING WHERE LINE AND HUB MEET. PICC LINE WAS REMOVED. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    444463 PRO-PICC-MAXIMUM BARRIER KIT PICC LINE/ CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG TERM LJS MEDCOMP (MEDICAL COMPONENTS, INC) MRCTP52029 MMAJ120

    Patients

    Seq Age Sex Outcome Treatment
    1 8 MO Required Intervention