BEUDAMED
    FDA Adverse Event Other Summary report: N

    CATHETER

    MDR report key: 925576 · Received October 8, 2007

    Report

    Report Number
    2026095-2007-00053
    Event Type
    Other
    Date Received
    October 8, 2007
    Report Date
    September 6, 2007
    Manufacturer
    I-FLOW CORP.
    Product Code
    BSO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE DEVICE INVOLVED IN THIS INCIDENT WAS REPORTED AVAILABLE, BUT HAS NOT BEEN RETURNED TO I-FLOW CORPORATION FOR EVALUATION. WITHOUT THE PART NUMBER, LOT NUMBER, OR ACTUAL PRODUCT, A COMPLETE ANALYSIS CANNOT BE CONDUCTED. THE INFORMATION CONTAINED HEREIN IS BASED ON THE INFORMATION PROVIDED BY THE INITIAL REPORTER. IF ADDITIONAL INFORMATION THAT IS PERTINENT TO THIS EVENT BECOMES AVAILABLE, I-FLOW WILL SUBMIT A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    THE I-FLOW SALES REPRESENTATIVE WAS HANDED A CATHETER KIT IN A SPECIMEN CONTAINER WITH NO PRODUCT OF BACKGROUND INFO. CUSTOMER HAS NO OTHER INFORMATION OTHER THAN THE CATHETER BROKE OFF INSIDE THE PT AND THE SURGERY WAS KNEE RELATED. CUSTOMER HAS HAD THIS CATHETER SINCE APRIL 2007.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CATHETER CATHETER BSO I-FLOW CORP. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention