BEUDAMED
    FDA Adverse Event Other Summary report: N

    ON-Q SILVER SOAKER

    MDR report key: 1081624 · Received July 25, 2008

    Report

    Report Number
    2026095-2008-00091
    Event Type
    Other
    Date Received
    July 25, 2008
    Date of Event
    June 1, 2008
    Report Date
    June 27, 2008
    Manufacturer
    I-FLOW CORP.
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE INFORMATION CONTAINED HEREIN IS BASED ON THE INFO PROVIDED BY THE INITIAL REPORTER. IT WAS INDICATED THAT THE DEVICE WILL NOT BE RETURNED, AND, THEREFORE, NOT AVAILABLE FOR EVALUATION AND INVESTIGATION. WITHOUT THE ACTUAL PRODUCT OR LOT NUMBER, A COMPLETE ANALYSIS CANNOT BE CONDUCTED. IT WAS REPORTED THAT THE CATHETER MOST LIKELY WAS CAUGHT IN THE SUTURE, AND BROKEN WHEN PULLED. BASED ON THIS INFO PROVIDED, THE TECHNIQUE USED IN THE REMOVAL OF THE CATHETER MAY HAVE CAUSED THE REPORTED INCIDENT. THE DIRECTIONS FOR USE CONTAIN A WARNING THAT STATES " DO NOT SUTURE THROUGH CATHETER TO AVOID CATHETER BREAKAGE DURING REMOVAL." IN ADDITION, 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." THE BULLETIN WAS PROVIDED TO THE REPORTER OF THIS COMPLAINT. IF ADDITIONAL 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 THERE WAS DIFFICULTY REMOVING A CATHETER. DOCTOR TRIED TO REMOVE; HOWEVER, THE CATHETER MOST LIKELY CAUGHT ON A SUTURE, AND WHEN HE PULLED, THE CATHETER BROKE. PATIENT WAS FINE AND OBTAINED RELIEF FROM THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-Q SILVER SOAKER CATHETER MEB I-FLOW CORP. PM050-A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other