BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRODUCERS

    MDR report key: 3062861 · Received April 12, 2013

    Report

    Report Number
    2026095-2013-00061
    Event Type
    Injury
    Date Received
    April 12, 2013
    Date of Event
    April 1, 2013
    Report Date
    April 1, 2013
    Manufacturer
    I-FLOW LLC
    Product Code
    GDF
    PMA / PMN Number
    K063234
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: AT THE TIME OF THIS REPORT, SAMPLE HAD NOT BEEN RECEIVED, BUT WAS REPORTED TO BE AVAILABLE. RESULTS: ONCE THE SAMPLE IS RECEIVED, AN EVAL AND INVESTIGATION WILL BE CONDUCTED. CONCLUSIONS: A F/U REPORT WILL BE FILED WHEN THE INVESTIGATION HAS BEEN COMPLETED. INFO FROM THIS INCIDENT WILL BE INCLUDED IN OUR PRODUCT COMPLAINT AND MDR TREND REPORTING SYSTEM. ADD'L INVESTIGATION MAY ARISE FROM ONGOING ANALYSIS, TREND INFO, OR OTHER ANALYSIS AS APPROPRIATE.

    Description of Event or Problem · 1

    DRUG/DILUENT: UNK. FILL VOLUME: UNK. FLOW RATE: UNK. PROCEDURE: WHIPPLE. CATHPLACE: BI-LATERALLY TO MIDLINE INCISION. PHYSICIAN REPORTED THAT HE USED A T17X8 TUNNELER. SURGEON PEELED THE T-PEEL SHEATH WHICH BROKE, LEAVING A 6 INCH SECTION IN PT. INCISION WAS REOPENED AND PIECE WAS REMOVED. DATE OF SURGERY (B)(6) 2013, PT IS IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    158148 INTRODUCERS TUNNELER GDF I-FLOW LLC T17X8 0200668652

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other