BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWER INJECT PICC

    MDR report key: 3904588 · Received June 6, 2014

    Report

    Report Number
    3904588
    Event Type
    Malfunction
    Date Received
    June 6, 2014
    Date of Event
    May 10, 2014
    Report Date
    June 6, 2014
    Manufacturer
    NAVILYST MEDICAL INC., AN ANGIODYAMICS COMPANY
    Product Code
    LJS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    EXTENSION TUBING WAS CONNECTED DIRECTLY TO THE CENTRAL LINE (HUB TO HUB) IN ORDER FOR THE PATIENT TO GO TO MRI AND WHEN THE NURSES ATTEMPTED TO DISCONNECT THE TUBING IT BROKE OFF IN THE PICC CATHETER. THE PICC HAD TO BE EXCHANGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331892 POWER INJECT PICC CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 LJS NAVILYST MEDICAL INC., AN ANGIODYAMICS COMPANY * 1310020

    Patients

    Seq Age Sex Outcome Treatment
    1 10 MO