BEUDAMED
    FDA Adverse Event Other Summary report: N

    FAST I

    MDR report key: 606327 · Received January 8, 2004

    Report

    Report Number
    9615387-2004-00013
    Event Type
    Other
    Date Received
    January 8, 2004
    Date of Event
    December 26, 2003
    Report Date
    January 8, 2004
    Manufacturer
    PYNG MEDICAL CORP.
    Product Code
    FMI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON FIRST ATTEMPT BY THE CAREGIVER THAT INFUSION TUBE DID NOT SET IN THE STERNUM. A SECOND DEVICE WAS USED, THE SITE RE-PREPPED AND INSERTION SUCCESSFUL SECURING ACCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FAST I STERNAL I.O. FMI PYNG MEDICAL CORP. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other