BEUDAMED
    FDA Adverse Event Other Summary report: N

    FAST1 INTRAOSSESOUS INFUSION SYSTEM

    MDR report key: 1620152 · Received February 26, 2010

    Report

    Report Number
    9615387-2010-00001
    Event Type
    Other
    Date Received
    February 26, 2010
    Date of Event
    January 23, 2010
    Report Date
    February 26, 2010
    Manufacturer
    PYNG MEDICAL CORP.
    Product Code
    FMI
    PMA / PMN Number
    K080865
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFUSION TUBE WAS INSERTED AND FUNCTIONED WELL FOR ITS INTENDED USE OF INTRAOSSEOUS INFUSION. THE PATIENT WAS ELDERLY MALE (B) (6), WITH ADVANCED LUNG CANCER, RESPIRATORY FAILURE, DIABETES, AND HYPERCALCEMIA. THE MEDICAL STAFF ATTEMPTED TO REMOVE THE INFUSION TUBE, BUT WERE UNABLE. MULTIPLE ATTEMPTS BY MULTIPLE INDIVIDUALS. ULTIMATELY, THE PORTAL TIP AND INFUSION TUBE SEPARATED AND THE PORTAL TIP WAS LEFT INSIDE THE PATIENT. MEDICAL STAFF ULTIMATELY PERFORMED A CUT-DOWN AND SURGICALLY REMOVED THE PORTAL TIP. THE PATIENT HAS RECOVERED FROM THIS. NO EVALUATION OF THE DEVICE IS POSSIBLE, AS IT WAS DISCARDED BY THE MEDICAL STAFF AT THE FACILITY. THE FACILITY DID FILE A MEDWATCH FORM WITH FDA ON THEIR OWN ON 02/05/2010 (B) (4). THE MEDWATCH REPORT FROM FACILITY DID CONCLUDE THAT USER ERROR IS A "LIKELY CONTRIBUTING FACTOR" (FOR THIS MDR). NOTE: PYNG MEDICAL IS FILING 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. 01-0017-001RTR 09061611

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other