BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 1948815 · Received December 17, 2010

    Report

    Report Number
    1948815
    Event Type
    Malfunction
    Date Received
    December 17, 2010
    Date of Event
    December 10, 2010
    Report Date
    December 17, 2010
    Manufacturer
    RYMED TECHNOLOGIES, INC
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHEN IV TUBING WAS DISCONNECTED FROM RYMED JUNIOR CAP BY PHYSICIAN, CAP NOTED TO HAVE HOLE IN THE SEPTUM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * NEEDLELESS INTERVENOUS CATHETER CAP FPA RYMED TECHNOLOGIES, INC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR