BEUDAMED
    FDA Adverse Event Other Summary report: N

    FAST1 INTRAOSSEOUS INFUSION SYSTEM

    MDR report key: 1461716 · Received June 10, 2009

    Report

    Report Number
    9615387-2009-00011
    Event Type
    Other
    Date Received
    June 10, 2009
    Date of Event
    September 13, 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. (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. CONCLUSION: NO KNOWN DEVICE MALFUNCTION. POSSIBLE OFF-PERPENDICULAR INSERTION AND PULLING BACK THE INTRODUCER TOWARDS THE END LEADING TO UNDER PENETRATION AND PULLING ON THE INFUSION TUBE.

    Description of Event or Problem · 1

    INSERTION DIFFICULTY. THE INTRODUCER WAS INSERTED INTO THE STERNUM AND THE BONE PROBE PENETRATED THE STERNUM. THE INTRODUCER WAS THEN WITHDRAWN, THE TWO PLASTIC GUIDES FELL AWAY (AS THEY SHOULD), BUT AS THE HANDLE WAS WITHDRAWN, THE INFUSION TUBE CAME WITH IT. (B) (4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FAST1 INTRAOSSEOUS INFUSION SYSTEM FMI PYNG MEDICAL CORP. 01-0017-002 06070814

    Patients

    Seq Age Sex Outcome Treatment
    1 Other