BEUDAMED
    FDA Adverse Event Other Summary report: N

    FAST1 INTRAOSSESOUS INFUSION SYSTEM

    MDR report key: 1676909 · Received May 6, 2010

    Report

    Report Number
    9615387-2010-00002
    Event Type
    Other
    Date Received
    May 6, 2010
    Date of Event
    October 1, 2009
    Report Date
    May 6, 2010
    Manufacturer
    PYNG MEDICAL CORP.
    Product Code
    FMI
    PMA / PMN Number
    K080865
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFUSION TUBE WAS INSERTED AND FUNCTIONED WELL FOR ITS INTENDED USE OF INTRAOSSEOUS INFUSION. THE USER REPORTED THAT THEY GOT FAST FLOW OF FLUIDS INTO THE PT FOR APPROX 10 MINUTES BEFORE INFILTRATION BEGAN TO OCCUR. THE USER SAID THAT THEY HAD INADVERTENTLY/ACCIDENTLY PULLED ON THE IV LINE WHILE TREATING THE PT. THIS LIKELY CAUSED THE INFUSION TUBE TO FALL OUT. THE PT WAS AN ADULT MALE, OF APPROX (B)(6), AND WAS SUFFERING FROM HYPOTHERMIA. THE PT WAS IN CARDIAC ARREST FOR AN UNDETERMINED LENGTH OF TIME PRIOR TO THE INITIATION OF CPR. THE PT DID NOT SURVIVE. THE ATTENDING PHYSICIAN STATED THAT THE INCIDENT MADE NO DIFFERENCE TO THE PT OUTCOME. NO EVAL OF THE DEVICE IS POSSIBLE, AS IT WAS DISCARDED AS SHARPS WASTE. NOTE: ACCORDING TO THE REPORTABLE EVENT DECISION RECORD THIS IS NOT A REPORTABLE EVENT. PYNG MEDICAL IS FILING THIS REPORT AS A CONSERVATIVE INTERPRETATION OF THE FDA REGULATIONS. IN THE ABUNDANCE OF CAUTION PYNG MEDICAL IS FILING THIS AS AN MDR.

    Description of Event or Problem · 1

    USER PULLED ON THE IV LINE. INFILTRATION OCCURRED AND THEN THE TUBE FELL OUT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FAST1 INTRAOSSESOUS INFUSION SYSTEM FMI PYNG MEDICAL CORP. 01-0017RTR NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other