BEUDAMED
    FDA Adverse Event Other Summary report: N

    FAST1 INTRAOSSESOUS INFUSION SYSTEM

    MDR report key: 1676910 · Received May 6, 2010

    Report

    Report Number
    9615387-2010-00003
    Event Type
    Other
    Date Received
    May 6, 2010
    Date of Event
    December 1, 2009
    Report Date
    May 6, 2010
    Manufacturer
    PYNG MEDICAL CORP.
    Product Code
    FMI
    PMA / PMN Number
    K080865
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER ATTEMPTED TO INSERT THE INFUSION TUBE, BUT GOT INFILTRATION IMMEDIATELY. THE USER SWITCHED TO USING IV. THE PT WAS AN ADULT FEMALE, OF APPROXIMATELY (B)(6), SUFFERING FROM HEPATIC ENCEPHALOPATHY WITH A GCS OF 3 WHEN THE MEDICS ARRIVED. THE PT SURVIVED TO RETURN HOME. NO EVAL OF THE DEVICE IS POSSIBLE, AS IT WAS DISCARDED AS SHARPS WASTE. PYNG MEDICAL IS FILING THIS REPORT AS A CONSERVATIVE INTERPRETATION OF THE FDA REGULATIONS. IN THE ABUNDANCE OF CAUTION PYNG MEDICAL IS FILING THIS AS AN MDR.

    Description of Event or Problem · 1

    INSERTION DIFFICULTY. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FAST1 INTRAOSSESOUS INFUSION SYSTEM FMI PYNG MEDICAL CORP. 01-0017RTR NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other