BEUDAMED
    FDA Adverse Event Other Summary report: N

    FAST1 INTRAOSSEOUS INFUSION SYSTEM

    MDR report key: 1914502 · Received November 30, 2010

    Report

    Report Number
    9615387-2010-00017
    Event Type
    Other
    Date Received
    November 30, 2010
    Date of Event
    November 4, 2010
    Report Date
    November 30, 2010
    Manufacturer
    PYNG MEDICAL CORP.
    Product Code
    FMI
    PMA / PMN Number
    K100124
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFUSION TUBE WAS SUCCESSFULLY INSERTED AS PART OF THE TRAINING SESSION ON MILITARY VOLUNTEERS. THE TRAINEE ATTEMPTED TO REMOVE THE INFUSION TUBE FROM THE VOLUNTEER; HOWEVER, THE INFUSION TUBE SEPARATED FROM THE PORTAL TIP, LEAVING THE PORTAL TIP IN THE VOLUNTEER'S CHEST. THE PORTAL TIP WAS SURGICALLY AND SUCCESSFULLY REMOVED FROM THE VOLUNTEER UNDER LOCAL ANESTHETIC. THE VOLUNTEER WAS WELL AFTER THE SURGICAL PROCEDURE. THE DEVICE IS UNDER EVALUATION AT PYNG MEDICAL CORP.

    Description of Event or Problem · 1

    REMOVAL DIFFICULTY OCCURRED DURING A TRAINING SESSION ON A VOLUNTEER. THE TUBING OF THE FAST1 SEPARATED FROM THE PORTAL. THE PORTAL REMAINED IN THE VOLUNTEER'S CHEST AND WAS REMOVED SURGICALLY. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FAST1 INTRAOSSEOUS INFUSION SYSTEM FMI PYNG MEDICAL CORP. 01-0042-001RTR 10101912

    Patients

    Seq Age Sex Outcome Treatment
    1 Other