BEUDAMED
    FDA Adverse Event Other Summary report: N

    ON-Q SILVERSOAKER

    MDR report key: 1418512 · Received July 15, 2009

    Report

    Report Number
    2026095-2009-00172
    Event Type
    Other
    Date Received
    July 15, 2009
    Date of Event
    June 12, 2009
    Report Date
    June 16, 2009
    Manufacturer
    I-FLOW CORP.
    Product Code
    BSO
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFO CONTAINED HEREIN IS BASED ON THE INFO PROVIDED BY THE INITIAL REPORTER. THE SAMPLE HAS NOT BEEN RECEIVED, BUT WAS REPORTED TO BE AVAILABLE FOR EVAL AND INVESTIGATION. WITHOUT THE ACTUAL PRODUCT OR LOT NUMBER, A COMPLETE ANALYSIS CANNOT BE CONDUCTED. I-FLOW HAS PREPARED A TECHNICAL BULLETIN IN ORDER TO PREVENT OR DECREASE CATHETER BREAKS ENTITLED: "TIP FOR PREVENTING IN-SITU CATHETER BREAKAGE WITH THE ON-Q POST-OP PAIN RELIEF SYSTEM." (1303971, REV. B). ALSO, IN THE PT GUIDELINE INSERT, I-FLOW HAD PROVIDED CATHETER REMOVAL INSTRUCTIONS TO ENSURE SAFE REMOVAL (1305285, REV. C). IT IS WORTH NOTING THAT I-FLOW'S CATHETERS ARE MADE OF A NON-TOXIC, MEDICAL-GRADE MATERIAL THAT MEETS ISO (B) (4) TISSUE COMPATIBILITY 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 ADD'L INFO THAT IS PERTINENT TO THIS EVENT BECOMES AVAILABLE, I-FLOW WILL SUBMIT A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NURSE WAS REMOVING THE CATHETERS OF THE DUAL ON-Q PUMP FROM THE PT, WHEN THE SECOND CATHETER GAVE HER RESISTANCE AND SNAPPED OFF IN PT. APPROX 22CM WAS LEFT IN THE PT; HOWEVER, NO X-RAY OR SCANS HAD BEEN DONE AT THE TIME OF THE REPORT. NURSE HAS BOTH OF THE CATHETERS SAVED FOR RETURN. THE CATHETER SEGMENT REMAINS IN THE PT AND THE PT IS IN EXCELLENT CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-Q SILVERSOAKER CATHETER BSO I-FLOW CORP. PMO25-A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other