BEUDAMED
    FDA Adverse Event Other Summary report: N

    FAST1 INTRAOSSEOUS INFUSION SYSTEM

    MDR report key: 1899117 · Received October 26, 2010

    Report

    Report Number
    9615387-2010-00015
    Event Type
    Other
    Date Received
    October 26, 2010
    Report Date
    October 22, 2010
    Manufacturer
    PYNG MEDICAL CORP.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT DOES NOT HAVE A 510(K) NUMBER. THE PRODUCT HAS (B)(4). AN ANALOGOUS PRODUCT SOLD IN THE US HAS 510(K) NUMBER K080865. STILL UNDER INVESTIGATION. THIS WAS REPORTED TO PYNG MEDICAL VIA A THIRD PARTY IN THE (B)(6). THE ONLY INFO PROVIDED TO PYNG MEDICAL, TO DATE, IS THAT THIS EVENT OCCURRED, THE PT WAS A FOREIGN NATIONAL ((B)(6)) AND THAT THE THIRD PARTY WAS TRYING TO RETRIEVE THE PARTS FOR RETURN TO PYNG MEDICAL AND OBTAIN CLEARANCE FOR RELEASE OF A VIDEO RECORDING TAKEN DURING THE EVENT. THE COMPLAINANT WAS CONTACTED ON THE (B)(4), ASKING FOR RETURN OF THE DEVICE AND FOR SPECIFIC DETAILS REGARDING THE EVENT. PYNG MEDICAL WAS TOLD THAT THE COMPLAINANT WAS WORKING ON GETTING THE REQUESTED INFO. THE COMPLAINANT WAS CONTACTED AGAIN ON THE (B)(4), ASKING IF THEY HAD RECEIVED ANY FURTHER INFO REGARDING THIS EVENT. THEY RESPONDED THAT THEY WERE STILL WAITING ON INFO. NO FURTHER INFO HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 1

    REMOVAL DIFFICULTY. IT WAS REPORTED THAT "THE METAL TIP OF THE INFUSION TUBE WAS LEFT IN THE PT FOLLOWING REMOVAL." (B)(4).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Other