BEUDAMED
    FDA Adverse Event Other Summary report: N

    FAST1 INTRAOSSEOUS INFUSION SYSTEM

    MDR report key: 1461715 · Received June 10, 2009

    Report

    Report Number
    9615387-2009-00010
    Event Type
    Other
    Date Received
    June 10, 2009
    Date of Event
    April 1, 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
    CA
    Reporter Occupation
    PHYSICIAN

    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. IT WAS REPORTED THAT THE FAST1 WAS INSERTED SUCCESSFULLY NAD HAD FUNCTIONED AS INTENDED, ALLOWING INFUSION OF FLUIDS INTO THE PATIENT. AT THE RECEIVING HEALTHCARE FACILITY, THE MD HAD DIFFICULTY REMOVING THE INFUSION TUBE FROM THE PATIENT. AS REPORTED BY THE MD, THE MD USED THE REMOVAL TOOL AS DIRECTED, THREADING THE TOOL DOWN THE INFUSION TUBE, BUT IT KEPT TURNING. HE THEN PULLED ON THE REMOVER TOOL AND THE INFUSION TUBE CAME OUT, BUT THE PORTAL WAS LEFT BEHIND THE PATIENT. THE PORTAL WAS REMOVED SUCCESSFULLY USING SURGICAL INTERVENTION. BECAUSE PYNG MEDICAL DID NOT RECEIVE THE PARTS BACK, A FULL INVESTIGATION COULD NOT BE PERFORMED. THIS PRODUCT ISSUE HAS BEEN ADDRESSED BY ELIMINATION OF THE REMOVER TOOL. AN ANALOGOUS PRODUCT WAS CLEARED BY THE FDA THROUGH 510 (K) SUBMISSION K072487.

    Description of Event or Problem · 1

    REMOVAL DIFFICULTY. THE PORTAL WAS NOT THREADED CORRECTLY WITH THE REMOVER TOOL. THE TUBING CAME AWAY LEAVING THE PORTAL BEHIND. THE PORTAL WAS REMOVED SUCCESSFULLY USING SURGICAL INTERVENTION. (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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other