BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSYTE AUTOGUARD

    MDR report key: 1912724 · Received November 30, 2010

    Report

    Report Number
    1912724
    Event Type
    Malfunction
    Date Received
    November 30, 2010
    Date of Event
    September 23, 2010
    Report Date
    November 30, 2010
    Manufacturer
    BD MEDICAL
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US

    Narratives

    Description of Event or Problem · 1

    PATIENT CALLED TO REPORT THAT HE HAD PART OF AN IV CATHETER RETAINED IN HIS HAND AFTER HE WAS DISCHARGED IN THE LATE SUMMER OF 2010. THE PATIENT PRESENTED TO THE SURGEON'S OFFICE WHERE HE HAD THE PIECE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSYTE AUTOGUARD CATHETER, IV, SHORT TERM FOZ BD MEDICAL 381454 *

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR