BEUDAMED
    FDA Adverse Event Other Summary report: N

    ON-Q SILVERSOAKER CATHETER

    MDR report key: 1345047 · Received March 10, 2009

    Report

    Report Number
    2026095-2009-00047
    Event Type
    Other
    Date Received
    March 10, 2009
    Date of Event
    February 13, 2009
    Report Date
    February 13, 2009
    Manufacturer
    I-FLOW CORP.
    Product Code
    BSO
    PMA / PMN Number
    K063530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFO CONTAINED HEREIN IS BASED ON THE INFO PROVIDED BY THE INITIAL REPORTER AND THE SAMPLE SUBMITTED. RECEIVED ONE PARTIALLY FULL PUMP AND TWO CATHETERS FOR EVAL AND INVESTIGATION. VISUAL EXAMINATION OF THE FIRST CATHETER REVEALED THAT IT WAS OVERSTRETCHED AND WAS BROKEN AT ITS MID-BODY SECTION. BOTH CATHETER PARTS WERE RECEIVED. VISUAL EXAMINATION OF THE SECOND CATHETER REVEALED IT WAS RECEIVED COMPLETE AND FULLY INTACT. BASED ON THIS INFO RECEIVED AND THE EVAL OF THE CATHETER RECEIVED, THE TECHNIQUE USED IN THE REMOVAL OF THE CATHETER MOST LIKELY CONTRIBUTED THE REPORTED INCIDENT. A REVIEW OF THE LOT HISTORY FOUND NO OTHER CONFIRMED COMPLAINTS FOR THE REPORTED LOT. 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." IT IS WORTH NOTING THAT I-FLOW'S CATHETERS ARE MADE OF A NON-TOXIC, MEDICAL-GRADE MATERIAL THAT MEETS ISO ISSUE 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CATHETER BROKE WHILE SURGEON WAS REMOVING THE CATHETER FROM THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-Q SILVERSOAKER CATHETER CATHETER BSO I-FLOW CORP. PMO15-A 892285

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other