BEUDAMED
    FDA Adverse Event Other Summary report: N

    ON-Q CATHETER

    MDR report key: 1318380 · Received February 13, 2009

    Report

    Report Number
    2026095-2009-00021
    Event Type
    Other
    Date Received
    February 13, 2009
    Date of Event
    January 1, 2009
    Report Date
    January 19, 2009
    Manufacturer
    I-FLOW CORPORATION
    Product Code
    BSO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 INVOLVED IN THIS INCIDENT WAS NOT AVAILABLE FOR EVALUATION AND INVESTIGATION. WITHOUT THE ACTUAL PRODUCT, PART NUMBER, 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: "TIPS FOR PREVENTING IN-SITU CATHETER BREAKAGE WITH THE ON-Q POST-OP PAIN RELIEF SYSTEM." (REV. B). ALSO IN THE PATIENT GUIDELINE INSERT, I-FLOW HAS PROVIDED CATHETER REMOVAL INSTRUCTIONS TO ENSURE SAFE REMOVAL (REV. C). IT IS WORTH NOTING THAT I-FLOW'S CATHETERS ARE MADE OF A NON-TOXIC, MEDICAL-GRADE MATERIAL THAT MEETS ISO TISSUE COMPATIBILITY GUIDELINES FOR IMPLANTATION OF UP TO 3-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

    IT WAS REPORTED THAT THE CATHETER BROKE DURING REMOVAL. IT WAS STATED THAT THERE WAS NO BLACK MARKING OBSERVED DURING CATHETER REMOVAL AND THAT THE TUBING WAS SHORTER THAN THE OTHER SIDE. AN X-RAY WAS TAKEN AND SHOWED NO SIGNS OF THE CATHETER INSIDE, SO RETRIEVAL FOR THE DISTAL PORTION WAS NOT PERFORMED. THE PROXIMAL PORTION OF THE CATHETER WAS DISCARDED.

    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 UNK Other