BEUDAMED
    FDA Adverse Event Other Summary report: N

    FAST1 INTRAOSSEOUS INFUSION SYSTEM

    MDR report key: 1422969 · Received July 20, 2009

    Report

    Report Number
    9615387-2009-00031
    Event Type
    Other
    Date Received
    July 20, 2009
    Date of Event
    June 5, 2009
    Report Date
    July 17, 2009
    Manufacturer
    PYNG MEDICAL CORP.
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    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 K080865. THIS WAS INITIALLY REPORTED TO PYNG AS A SUCCESSFUL INSERTION. FROM THE EVAL OF THE DEVICE, AND AS REPORTED BY THE USER FACILITY, IT APPEARS THAT THE DEVICE HAD BEEN INSERTED CORRECTLY: PERPENDICULAR INSERTION WAS ACHIEVED. THE INFUSION TUBE WAS PLACED INTO THE MARROW SPACE AND FLUID FLOW WAS ACHIEVED. IT WAS REPORTED, IN THE LETTER RETURNED WITH THE DEVICE, THAT THE TUBING WAS PUT, "UNDER SOME PRESSURE", AND, "THE INFUSION SOLUTION CAME OUT OF THE INFUSION SITE. THE INFUSION TUBE WAS THEN PULLED OUT OF THE STERNUM WITHOUT MUCH EFFORT." IT APPEARS, FROM THE REPORT, THAT USER APPLIED PRESSURE ON THE TUBE MAY HAVE CAUSED THE TUBE TO BE DISLODGED. ACCORDING TO THE INITIAL REPORT OF THIS INCIDENT, THE PT WAS BEING TREATED FOR BREAST CANCER USING CHEMOTHERAPY AND LIKELY RADIATION THERAPY IN THE REGION OF THE STERNUM. EVAL OF THE REPORT OF THE PT BY PYNG MEDICAL'S MEDICAL DIRECTOR, THE PT WAS IN EXTREMIS BASED ON THE INITIAL VITAL SIGNS (LOUD RALES) AND PHYSIOLOGIC CONDITION (VOMITING FECAL MATTER) WHEN TREATMENT WAS INITIATED. ALSO, BREAST CANCER CAN CAUSE A WEAKENING OF BONE STRUCTURE SECONDARY TO METASTASIS AND RADIATION THERAPY CAN CAUSE A WEAKENING OF BONE STRUCTURE AND CHANGES TO NORMAL ANATOMY AND PHYSIOLOGY OF BONE MARROW. PYNG MEDICAL IS FILING THIS AS A CONSERVATIVE INTERPRETATION OF FDA REGULATIONS. IN THE ABUNDANCE OF CAUTION, PYNG IS FILING THIS AS AN MDR. CONCLUSION: TWO FAST1 DEVICES WERE RETURNED TO PYNG MEDICAL, BOTH DEVICES AS RECEIVED WERE RELEASED, THE FAST 1 NR.1 WAS PER THE REPORT RELEASED SUCCESSFULLY ON A PT, THE NEEDLE TIP DAMAGE SEEM TO INDICATE CORRECT INSERTION ANGLE, THE NEEDLE CLUSTER WAS NOT DEPLOYED INTO THE INTRODUCER DEEPLY PERHAPS FROM INSERTION INTO THICKER OVERLYING TISSUE. THE FAST1 NR.2 WAS RELEASED AS IT IS UNDERSTOOD THE DEVICE WAS FIRST ATTEMPTED ONTO THE PT THEN DEPLOYED INTO A TRAINING BLOCK, THE NEEDLE AND STYLET TIP DAMAGE ARE NOT CONCLUSIVE, HOWEVER, THE TIP DAMAGE SEEM TO INDICATE CORRECT INSERTION ALIGNMENT. THE PULL OFF FORCES OF THE INFUSION TUBE OFF THE STYLET FROM THE LUER CLIP AND STYLET SUPPORTS SUBSEQUENT TO DISLODGING THE FAT-LIKE MATERIAL AT THE STYLET/PORTAL INTERFACE ARE WITHIN SPEC 130+/-30G, WITH VALUES MEASURED BETWEEN 104G TO 151G.

    Description of Event or Problem · 1

    FAST1 INFUSION TUBE WAS REMOVED AFTER SEVERAL MINUTES OF INFUSION. (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 72 YR Other