BEUDAMED
    FDA Adverse Event Other Summary report: N

    ON-Q CATHETER

    MDR report key: 1914434 · Received November 22, 2010

    Report

    Report Number
    2026095-2010-00286
    Event Type
    Other
    Date Received
    November 22, 2010
    Report Date
    October 28, 2010
    Manufacturer
    I-FLOW CORPORATION
    Product Code
    BSO
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CATHETER BROKE OFF IN PT (ABOUT 4") WHEN REMOVED BY PHYSICIAN. SURGERY WAS ATTEMPTED, BUT FRAGMENT WAS NOT FOUND. FACILITY SAVED PUMP AND REMAINING CATHETER SEGMENTS (DUAL CATHETER). DATE OF EVENT: UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-Q CATHETER CATHETER BSO I-FLOW CORPORATION UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR