BEUDAMED
    FDA Adverse Event Other Summary report: N

    FASTI INTRAOSSEOUS INFUSION SYSTEM

    MDR report key: 1461711 · Received June 10, 2009

    Report

    Report Number
    9615387-2009-00012
    Event Type
    Other
    Date Received
    June 10, 2009
    Date of Event
    September 11, 2006
    Report Date
    June 10, 2009
    Manufacturer
    PYNG MEDICAL CORP.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT DOES NOT HAVE A 510(K) NUMBER. THE PRODUCT HAS (B)(4) AND (B)(4). AN ANALOGOUS PRODUCT SOLD IN THE US HAS 510 (K) NUMBER K970380. THE DISTRIBUTOR WAS RE-EDUCATED AND RETRAINED ON FAST1 INSERTION TECHNIQUES, IN PERSON, ON NOVEMBER 13TH, 2006.

    Description of Event or Problem · 1

    THE FAST1 WAS USED AFTER ONE OF THE IV LINES IN THE PT HAD BECOME DISLODGED. THE INFUSION TUBE WAS SUCCESSFULLY INSERTED INTO THE PT AND WAS USED SUCCESSFULLY FOR INFUSION OF FLUIDS FOR A TOTAL OF 7 TO 8 MINUTES, AFTER WHICH, IT WAS NOTICED THAT THE INFUSION TUBE APPEARED TO HAVE BECOME DISLODGED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FASTI INTRAOSSEOUS INFUSION SYSTEM FMI PYNG MEDICAL CORP. 01-0017-002

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other