BEUDAMED
    FDA Adverse Event Other Summary report: N

    FAST1 INTRAOSSEOUS INFUSION SYSTEM

    MDR report key: 1461686 · Received June 10, 2009

    Report

    Report Number
    9615387-2009-00020
    Event Type
    Other
    Date Received
    June 10, 2009
    Date of Event
    August 1, 2008
    Report Date
    May 26, 2009
    Manufacturer
    PYNG MEDICAL CORP.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT DOES NOT HAVE A 510 (K) NUMBER. (B) (4). AN ANALOGOUS PRODUCT SOLD IN THE U.S. HAS 510 (K) NUMBER K970380. NO FURTHER INFO WAS RECEIVED FORM THE RECEIVING HOSPITAL. WE WERE INFORMED BY THE HOSPITAL, IN A PHONE CALL MADE 12:13 PM, AUGUST 29, 2008, THAT ACCORDING TO THEIR POLICY NEITHER PT INFO NOR PRODUCT PARTS WERE AVAILABLE TO PYNG MEDICAL. THIS PRODUCT ISSUE HAS BEEN ADDRESSED BY ELIMINATION OF THE REMOVER TOOL. THE ANALOGOUS PRODUCT WAS CLEARED BY FDA THROUGH 510 (K) SUBMISSION K072487.

    Description of Event or Problem · 1

    REMOVAL DIFFICULTY. IO WAS INSERTED AND FUNCTIONED CORRECTLY. ON REMOVAL, THE REMOVER TOOL WAS THREADED INTO THE PORTAL. THE TIP SNAPPED AT THE THREAD. (B) (4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FAST1 INTRAOSSEOUS INFUSION SYSTEM FMI PYNG MEDICAL CORP. 01-0017-001 07091612

    Patients

    Seq Age Sex Outcome Treatment
    1 Other