BEUDAMED
    FDA Adverse Event Other Summary report: N

    ON-Q SILVERSOAKER

    MDR report key: 1728841 · Received June 11, 2010

    Report

    Report Number
    2026095-2010-00062
    Event Type
    Other
    Date Received
    June 11, 2010
    Date of Event
    May 1, 2010
    Report Date
    May 12, 2010
    Manufacturer
    I-FLOW CORP.
    Product Code
    BSO
    PMA / PMN Number
    K051401
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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 WAS DISCARDED BY THE CUSTOMER AND IS THEREFORE NOT AVAILABLE FOR EVALUATION AND INVESTIGATION. WITHOUT THE ACTUAL SAMPLE OR LOT NUMBER, A COMPLETE ANALYSIS CANNOT BE CONDUCTED. AS NO LOT NUMBER WAS PROVIDED, THE DEVICE HISTORY RECORD AND LOT HISTORY CANNOT BE REVIEWED. 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) THE PATIENT GUIDELINE INSERT, I-FLOW HAS PROVIDED CATHETER REMOVAL INSTRUCTIONS TO ENSURE SAFE REMOVAL (1305285, REV. C). THE DIRECTIONS FOR USE (DFU) (1306078, REV D) CLEARLY PROVIDE CAUTIONS AND DIRECTIONS ON CATHETER REMOVAL IF RESISTANCE IS ENCOUNTERED. 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 THEREFORE) 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, PRIOR TO THE PATIENT BEING RELEASED. SURGERY WAS ON MAY 5, 2010 AND THE PUMP WAS REMOVED APPROXIMATELY 4 DAYS LATER BY THE MEDICAL PARTNER. THE PHYSICIAN CONTACTED THE HOTLINE TO FIND OUT IF THE CATHETER WAS RADIO OPAQUE BECAUSE THE END OF THE CATHETER WAS STRETCHED AND SEEMED SURE THAT IT HAD BROKEN. A CT SCAN DID NOT LOCATE THE CATHETER SEGMENT. THE PUMP AND CATHETER WERE DISCARDED. THE PATIENT IS REPORTED TO BE DOING WELL AND WAS DISCHARGED WITH ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-Q SILVERSOAKER CATHETER BSO I-FLOW CORP. PM028-A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1