BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INVISION-PLUS NEUTRAL CAP

    MDR report key: 1920586 · Received November 22, 2010

    Report

    Report Number
    1920586
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Date of Event
    November 20, 2010
    Report Date
    November 22, 2010
    Manufacturer
    RYMED TECHNOLOGIES, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US

    Narratives

    Description of Event or Problem · 1

    EVENT 1: PT ON TPN/LIPIDS WHICH REQUIRES A DAILY CAP CHANGE. NURSE DISCONNECTED THE TUBING FROM THE POSI FLOW CAP AND SMALL AMOUNT OF BLOOD LEAKED FROM CAP BEFORE IT COULD BE CLAMPED. LINE WAS NOT LEAKING WHEN TPN/LIPIDS WERE RUNNING. ONCE CAP CHANGED, NURSE NOTICED A SMALL HOLE IN THE GREEN RUBBER PART THAT IS NORMALLY DEPRESSED WHEN ACCESSED.EVENT 2: AFTER UNHOOKING SYRINGE PUMP TUBING FROM THE CAP OF PATIENT'S HICKMAN, BLOOD STARTED COMING OUT OF THE TOP OF THE CAP. CAP REMOVED AND CHANGED PER PROTOCOL USING STERILE TECHNIQUE. FRAYED HOLE NOTED IN TOP OF CAP UPON REMOVAL.====================== HEALTH PROFESSIONAL'S IMPRESSION======================A SMALL CUT OR HOLE WAS SEEN IN THE GREEN RUBBER PART OF THE CAPS INVOLVED WITH BOTH EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INVISION-PLUS NEUTRAL CAP IV SET, CONNECTOR FPA RYMED TECHNOLOGIES, INC. RYM5001A *

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR
    2 8 YR