BEUDAMED
    FDA Adverse Event Other Summary report: N

    FASTI INTRAOSSEOUS INFUSION SYSTEM

    MDR report key: 1461705 · Received June 10, 2009

    Report

    Report Number
    9615387-2009-00029
    Event Type
    Other
    Date Received
    June 10, 2009
    Date of Event
    August 1, 2007
    Report Date
    June 10, 2009
    Manufacturer
    PYNG MEDICAL CORP.
    Product Code
    FMI
    PMA / PMN Number
    K970380
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS BEING USED IN A NON-CLINICAL ENVIRONMENT IN A TRAINING SESSION. PYNG MEDICAL IS FILING THIS AS A CONSERVATIVE INTERPRETATION OF FDA REGULATIONS. IN THE ABUNDANCE OF CAUTION, PYNG IS FILING THIS AS AN MDR. THE DEVICE WAS SUCCESSFULLY REMOVED USING A SECOND FAST1 REMOVAL TOOL. THIS PRODUCT ISSUE HAS BEEN ADDRESSED BY ELIMINATION OF THE REMOVER TOOL. THE ANALAGOUS PRODUCT WAS CLEARED BY THE FDA THROUGH 510(K) SUBMISSION K07248.

    Description of Event or Problem · 1

    REMOVER TOOL ISSUE DURING TRAINING SESSION. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FASTI INTRAOSSEOUS INFUSION SYSTEM FMI PYNG MEDICAL CORP. 01-0017/01-0042 07021413

    Patients

    Seq Age Sex Outcome Treatment
    1 Other
    2