BEUDAMED
    FDA Adverse Event Other Summary report: N

    FAST1 INTRAOSSESOUS INFUSION SYSTEM

    MDR report key: 1676911 · Received May 6, 2010

    Report

    Report Number
    9615387-2010-00004
    Event Type
    Other
    Date Received
    May 6, 2010
    Date of Event
    April 20, 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
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFUSION TUBE WAS INSERTED AND FUNCTIONED WELL FOR ITS INTENDED PURPOSE OF INTRAOSSEOUS INFUSION. IT WAS WHEN THE INFUSION TUBE WAS BEING REMOVED THAT THE TUBING SEPARATED FROM THE METAL PORTAL TIP. THE PORTAL TIP WAS LEFT IN THE PT. THE PT WAS A (B) (6) MALE, OF APPROX (B) (6), WHO HAD ATTEMPTED SUICIDE. THE PT SURVIVED TO BE TRANSFERRED TO A PSYCHIATRIC WARD. THE PORTAL TIP WAS NOT REMOVED BEFORE THE PT'S TRANSFER AND REMAINS IN THE PT'S CHEST. THE DEVICE WAS NOT RETURNED TO THE MFR. 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

    REMOVAL 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 42 YR Other