BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FAST1 INTRAOSSEOUS INFUSION SYSTEM

    MDR report key: 2043037 · Received February 23, 2011

    Report

    Report Number
    9615387-2011-00001
    Event Type
    Malfunction
    Date Received
    February 23, 2011
    Date of Event
    February 11, 2011
    Report Date
    February 15, 2011
    Manufacturer
    PYNG MEDICAL CORP.
    Product Code
    FMI
    PMA / PMN Number
    K080865
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AT THE TIME OF REPORTING, THIS MDT THE FAST1 DEVICE HAS NOT BEEN RETURNED TO PYNG MEDICAL CORP FOR FORMAL EVAL. A VIDEO OF THE INCIDENT AND THE ACTUAL DEVICE ARE BEING SENT TO PYNG. UPON RECEIPT OF THESE ITEMS A THOROUGH REVIEW WILL BE CONDUCTED AND CONCLUSIONS DRAWN.

    Description of Event or Problem · 1

    INSERTION DIFFICULTY. DURING A TRAINING PROCEDURE FOR EMERGENCY MEDICAL TECHNICIANS (B)(4) THE TRAINEE ATTEMPTED TO DEPLOY THE FAST1 INTRAOSSEOUS INFUSION SYSTEM INTO A LIVE VOLUNTEER. THE TRAINEE USED THE DEVICE ACCORDING TO THE IFU; HOWEVER, THE INFUSION TUBE OF THE FAST1 DID NOT INSERT AND REMAIN IN THE SUBJECT'S MANUBRIUM. AS STATED THIS WAS ON A VOLUNTEER DURING A TRAINING SESSION. PYNG MEDICAL CORP'S REFERENCE # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FAST1 INTRAOSSEOUS INFUSION SYSTEM FMI PYNG MEDICAL CORP. 01-0042-001RTR UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other