BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRO-PICC - MAXIMUM BARRIER KIT

    MDR report key: 8615558 · Received May 15, 2019

    Report

    Report Number
    MW5086668
    Event Type
    Injury
    Date Received
    May 15, 2019
    Date of Event
    May 3, 2019
    Report Date
    May 14, 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 PICC LINE NOTED TO HAVE CRACKED HUB AND LEAKING. LINE REMOVED. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404027 PRO-PICC - MAXIMUM BARRIER KIT PICC LINE / CATHETER INTRAVASCULAR THERAPEUTIC, LONG TERM GREATER THAN 30 DAYS LJS MEDCOMP (MEDICAL COMPONENTS, INC. ) MR17035206MB MMAT250

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention