BEUDAMED
    FDA Adverse Event Other Summary report: N

    ON-Q INTRODUCER NEEDLES

    MDR report key: 1971928 · Received January 20, 2011

    Report

    Report Number
    2026095-2011-00341
    Event Type
    Other
    Date Received
    January 20, 2011
    Date of Event
    December 28, 2010
    Report Date
    December 28, 2010
    Manufacturer
    I-FLOW CORPORATION
    Product Code
    BSO
    PMA / PMN Number
    K063234
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE HAS NOT YET BEEN RECEIVED, BUT WAS REPORTED TO BE AVAILABLE. THE SAMPLE WILL BE EVALUATED WHEN RECEIVED AND A F/U REPORT WILL BE FILED.

    Description of Event or Problem · 1

    DURING REMOVAL, THE SHEATH HANDLE BROKE, AND THE SHEATH WAS "SWALLOWED" BY THE PT'S BODY, BUT WAS RETRIEVED WITH FORCEPS. THE ENTIRE SHEATH WAS REMOVED FROM THE PT AND RETAINED FOR RETURN. NO ADVERSE EVENT OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-Q INTRODUCER NEEDLES SHEATH BSO I-FLOW CORPORATION ACC03 884864

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR