BEUDAMED
    FDA Adverse Event Other Summary report: N

    FAST1 INTRAOSSEOUS INFUSION SYSTEM

    MDR report key: 1461720 · Received June 10, 2009

    Report

    Report Number
    9615387-2009-00009
    Event Type
    Other
    Date Received
    June 10, 2009
    Date of Event
    February 15, 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
    NOT APPLICABLE

    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. FOLLOW-UP TRAINING MATERIALS WERE SENT MARCH 15TH, 2006. THE DEVICE WAS RECEIVED IN A BOX WITH PAPER PACKAGING MATERIAL PLACED IN A ZIPLOCK BIOHAZARD BAG. THE FAST1 POUCH WITH LABEL, INSTRUCTION FOR USE, UNOPENED REMOVER, DOME, AND SYRINGE WERE RETURNED ALONG WITH THE INTRODUCER. THE INTRODUCER HAD BOTH THE POST-USE SHARPS PLUG AND PRE-USE SHARPS CAP ON. CONCLUSION: NO KNOWN DEVICE FAILURE FROM RELEASE TESTING COMPLETED AT PMC. NEEDLE TIP DAMAGE INDICATES OFF-PERPENDICULAR INSERTION LIKELY LEADING TO UNSUCCESSFUL INSERTION. INFORM CUSTOMER OF FINDINGS, RECOMMEND REFRESHING IN USE OF FAST1 WITH DEMO INTRODUCER AND SIMSTERNS, PMC TO SEND INSERTION AND REMOVAL POSTERS.

    Description of Event or Problem · 1

    UNSUCCESSFUL INSERTION. STERNAL IO DIDN'T RELEASE. (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 04111513

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Other