BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRO-PICC-MAXIMUM BARRIER KIT

    MDR report key: 8650246 · Received May 28, 2019

    Report

    Report Number
    MW5086953
    Event Type
    Injury
    Date Received
    May 28, 2019
    Date of Event
    April 4, 2019
    Report Date
    May 23, 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

    ON (B)(6) 2019 LINE WAS NOTED TO HAVE A CRACK IN THE HUB WITH LEAKING. LINE REMOVED. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437873 PRO-PICC-MAXIMUM BARRIER KIT CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM LJS MEDCOMP(MEDICAL COMPONENTS, INC) MRCTP52029

    Patients

    Seq Age Sex Outcome Treatment
    1 9 MO Required Intervention