BEUDAMED
    FDA Adverse Event Other Summary report: N

    ON-Q PAINBUSTER

    MDR report key: 1193525 · Received October 7, 2008

    Report

    Report Number
    2026095-2008-00162
    Event Type
    Other
    Date Received
    October 7, 2008
    Date of Event
    June 19, 2008
    Report Date
    September 12, 2008
    Manufacturer
    I-FLOW CORP.
    Product Code
    MEB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THIS INCIDENT WAS NOT AVAILABLE FOR EVALUATION AND INVESTIGATION. WITHOUT THE ACTUAL PRODUCT, A PART NUMBER, OR A LOT NUMBER, A COMPLETE ANALYSIS CANNOT BE CONDUCTED. THE INFORMATION CONTAINED HEREIN IS BASED ON THE INFORMATION PROVIDED BY THE INITIAL REPORTER. DURING ANOTHER SURGICAL PROCEDURE IN 2008, A PIECE OF TUNNELER SHEATH WAS FOUND INSIDE THE PT. THE PIECE OF SHEATH WAS REMOVED. THIS MOST LIKELY HAD BROKEN OFF DURING A PREVIOUS SURGERY. THE DFU CONTAINS BOTH A WARNING AND A CAUTION CONCERNING SHEATH BREAKAGE. THE WARNING STATES: "DO NOT REINSERT A PARTIALLY OR COMPLETELY WITHDRAWN NEEDLE AS THIS CAN DAMAGE THE SHEATH AND BREAK OFF IN PT UPON SHEATH REMOVAL." THE CAUTION STATES: "WHILE HOLDING CATHETER TIP (1), WITHDRAW SHEATH COMPLETELY FROM PUNCTURE SITE PRIOR TO SPLITTING TO AVOID SHEATH BREAKING OFF IN PT." 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

    FOLLOWING SURGERY, A SECTION OF A TUNNELER SHEATH WAS FOUND INSIDE THE PT THAT HAD BEEN LEFT FROM A PREVIOUS SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-Q PAINBUSTER INFUSION PUMP MEB I-FLOW CORP. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other