BEUDAMED
    FDA Adverse Event Other Summary report: N

    F.A.S.T.I

    MDR report key: 655410 · Received December 20, 2005

    Report

    Report Number
    9615387-2005-00023
    Event Type
    Other
    Date Received
    December 20, 2005
    Date of Event
    November 1, 2005
    Report Date
    November 29, 2005
    Manufacturer
    PYNG MEDICAL CORP.
    Product Code
    FMI
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    NO REMOVAL TOOL WITH PATIENT TO REMOVE INFUSION TUBING. MD CONTACTED PYNG MEDICAL CORP. FOR INFO ON REMOVING INFUSION TUBING. IN 2004 PYNG MEDICAL CORP. (PMC) WAS CONTACTED BY A DR REGARDING REMOVING THE FAST1 SYSTEM INFUSION TUBING. IN 2005 PYNG MEDICAL CORP. (PMC) WAS CONTACTED BY A DR REGARDING REMOVING THE FAST1 SYSTEM INFUSION TUBING. THE DR. INFORMED PMC THAT THE INFUSION TUBING WAS LIKELY IN THE PT FOR OVER A WEEK. THE PT HAD BEEN TRANSFERRED FROM ANOTHER FACILITY AND THE REMOVAL TOOL WAS NOT WITH THE PT. PMC INFORMED THE DR THAT WITH THE ABSENCE OF THE REMOVAL TOOL, THE INFUSION TUBING COULD BE REMOVED FROM THE PT WITH A SMALL INCISION. PMC FOLLOWED-UP WITH THE DR IN 2005. DR. INFORMED PMC THAT THE TUBING INCLUDING THE METAL PORTAL TIP WAS REMOVED FROM THE PT AND THAT THE PT WAS STABLE. NO INFO OF THE INSERTION OR THE PRIOR FACILITY. NO FURTHER ACTION, FILED CLOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 F.A.S.T.I INTRAOSSEOUS INFUSION SYSTEM FMI PYNG MEDICAL CORP. FAST 1 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other