BEUDAMED
    FDA Adverse Event Other Summary report: N

    ON-Q SILVERSOAKER

    MDR report key: 1614903 · Received February 18, 2010

    Report

    Report Number
    2026095-2010-00017
    Event Type
    Other
    Date Received
    February 18, 2010
    Date of Event
    January 22, 2010
    Report Date
    January 22, 2010
    Manufacturer
    I-FLOW CORPORATION
    Product Code
    BSO
    PMA / PMN Number
    K063530
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION CONTAINED HEREIN IS BASED ON THE INFORMATION PROVIDED BY THE INITIAL REPORTER. THE DEVICE IS NOT AVAILABLE FOR EVALUATION AND INVESTIGATION. WITHOUT THE ACTUAL SAMPLE OR LOT NUMBER, A COMPLETE ANALYSIS CANNOT BE CONDUCTED. AS NO LOT NUMBER WAS PROVIDED, THE DEVICE HISTORY RECORD AND LOT HISTORY CANNOT BE REVIEWED. I-FLOW HAS PREPARED A TECHNICAL BULLETIN IN ORDER TO PREVENT OR DECREASE CATHETER BREAKS ENTITLED: "TIPS FOR PREVENTING IN-SITU CATHETER BREAKAGE WITH THE ON-Q POST-OP PAIN RELIEF SYSTEM." (1303971, REV. B). THE PATIENT GUIDELINE INSERT, I-FLOW HAS PROVIDED CATHETER REMOVAL INSTRUCTIONS TO ENSURE SAFE REMOVAL (1305285, REV. C). THE DIRECTIONS FOR USE (DFU) (1306078, REV. C) CLEARLY PROVIDE CAUTIONS AND DIRECTIONS ON CATHETER REMOVAL IF RESISTANCE IS ENCOUNTERED. IT IS WORTH NOTING THAT I-FLOW'S CATHETERS ARE MADE OF NON-TOXIC, MEDICAL-GRADE MATERIAL THAT MEETS ISO 10993-1 TISSUE COMPATABILITY GUIDELINES FOR IMPLANTATION OF UP TO 30-DAYS; COMPLICATIONS MAY ARISE IF A CATHETER (OR PORTION THEREOF) IS LEFT IN THE BODY FOR LONGER THAN THIS PERIOD OF TIME. 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

    RESISTANCE WAS NOTED DURING CATHETER REMOVAL AND CATHETER BROKE, LEAVING APPROXIMATELY 2 CM IN THE PATIENT. DOCTOR THINKS, CATHETER WAS CAUGHT ON A SUTURE. IT IS UNKNOWN IF THE DISTAL PORTION OF THE CATHETER WILL BE REMOVED FROM PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-Q SILVERSOAKER CATHETER BSO I-FLOW CORPORATION PM025-A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other