BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEGUARD SAFETY INFUSION SET WITH SMARTSITE

    MDR report key: 2932442 · Received January 24, 2013

    Report

    Report Number
    2245270-2013-00001
    Event Type
    Malfunction
    Date Received
    January 24, 2013
    Date of Event
    December 10, 2012
    Report Date
    January 24, 2013
    Manufacturer
    VYGON MANUFACTURING
    Product Code
    FPA
    PMA / PMN Number
    K013871
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MALFUNCTIONING DEVICE WAS RETURNED TO VYGON FOR EVALUATION. A COMPLAINT INVESTIGATION IS BEING PERFORMED AND VYGON WILL SEND A FOLLOW-UP MDR WITH-IN THIRTY DAYS OF ITS COMPLETION.

    Description of Event or Problem · 1

    A PATIENT'S IMPLANTED PORT WAS ACCESSED WITH CLGY-2234 HUBER SET. THE PATIENT ROLLED ON SIDE AND THE HUBER SET TUBING WAS UNDER CLOTHING. THE PATIENT COMPLAINED OF WET CLOTHING, WHEN EXAMINED THE PATIENT'S CLOTHING WAS SIGNIFICANTLY WET FROM INFUSATE (SALINE) AND BLOOD THAT BACKED UP FROM THE PORT. THE LEAKAGE WAS FOUND TO BE COMING FROM DISTAL INJECTION PORT JUST BELOW THE CLAVE ATTACHMENT. THE PATIENT DID NOT EXPERIENCE ANY NEGATIVE OUTCOME FROM THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34760 LIFEGUARD SAFETY INFUSION SET WITH SMARTSITE HUBER NEEDLE SET FPA VYGON MANUFACTURING CLGY-2234 1203174

    Patients

    Seq Age Sex Outcome Treatment
    1