BEUDAMED
    FDA Adverse Event Other Summary report: N

    ON-Q SILVERSOAKER

    MDR report key: 1579929 · Received January 8, 2010

    Report

    Report Number
    2026095-2009-00301
    Event Type
    Other
    Date Received
    January 8, 2010
    Date of Event
    December 1, 2009
    Report Date
    December 11, 2009
    Manufacturer
    I-FLOW CORPORATION
    Product Code
    BSO
    PMA / PMN Number
    K051401
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION CONTAINED HEREIN IS BASED ON THE INFORMATION PROVIDED BY THE INITIAL REPORTER. THE SAMPLE HAS NOT BEEN RECEIVED, BUT WAS REPORTED TO BE AVAILABLE FOR EVALUATION AND INVESTIGATION. WITHOUT THE ACTUAL PRODUCT OR LOT NUMBER, A COMPLETE ANALYSIS CANNOT BE CONDUCTED. BASED ON THIS INFORMATION RECEIVED, THE TECHNIQUE USED IN THE REMOVAL OF THE CATHETER MOST LIKELY CONTRIBUTED TO THE REPORTED INCIDENT. THE ON-Q CATHETER DIRECTIONS FOR USE INCLUDE CATHETER REMOVAL INSTRUCTIONS TO ENSURE SAFE REMOVAL (1306078, REV. C). 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." (1303971, REV. B). A REVIEW OF THE LOT HISTORY FOUND NO OTHER COMPLAINTS FOR CATHETER BREAK. IT IS WORTH NOTING THAT I-FLOW'S CATHETERS ARE MADE OF A NON-TOXIC, MEDICAL-GRADE MATERIAL THAT MEETS ISO 10993-1 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 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 PATIENT CAME IN TO HAVE HER CATHETER REMOVED AND THE FIRST CATHETER CAME OUT FINE. THE SURGEON MET RESISTANCE WITH THE SECOND CATHETER AND PULLED, AND THE CATHETER BROKE. IT WAS STATED THAT THERE IS A POSSIBLE 2 INCHES OF THE CATHETER REMAINING IN THE PATIENT'S ABDOMEN. THE SURGEON IS WAITING UNTIL THE DRAINS COME OUT TO PERFORM ANY RADIO IMAGING.

    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