BEUDAMED
    FDA Adverse Event Other Summary report: N

    FAST1 INTRAOSSEOUS INFUSION SYSTEM

    MDR report key: 1461683 · Received June 10, 2009

    Report

    Report Number
    9615387-2009-00019
    Event Type
    Other
    Date Received
    June 10, 2009
    Date of Event
    May 1, 2008
    Report Date
    June 10, 2009
    Manufacturer
    PYNG MEDICAL CORP.
    Product Code
    FMI
    PMA / PMN Number
    K970380
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PYNG MEDICAL MADE SEVERAL RECENT CALLS TO THE COMPLAINANT ON MAY 26, 2009; JUNE 1, 2009; JUNE 4, 2009. A MESSAGE WAS LEFT EACH TIME. NO RESPONSE WAS RECEIVED BACK. PYNG MEDICAL MADE ANOTHER CALL ON JUNE 5, 2009 AND REACHED THE COMPLAINANT. THE COMPLAINANT REMEMBERED THE COMPLAINT. IT WAS RELATED TO A REMOVER TOOL THAT THEY COULDN'T "SPIN DOWN" INTO THE INFUSION TUBE. THE INFUSION TUBE WAS REMOVED SURGICALLY. ALL STAFF WERE RETRAINED BY THEIR DISTRIBUTOR. ABOUT THE SAME TIME THEY RECEIVED THE FAST1 WITHOUT THE REMOVER TOOL (K072487) AND HAVE HAD NO ISSUES SINCE.

    Description of Event or Problem · 1

    REMOVAL ISSUES. (B) (4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FAST1 INTRAOSSEOUS INFUSION SYSTEM FMI PYNG MEDICAL CORP. 01-0017/01-0042

    Patients

    Seq Age Sex Outcome Treatment
    1 Other