BEUDAMED
    FDA Adverse Event Other Summary report: N

    ON-Q SILVERSOAKER CATHETER

    MDR report key: 2560444 · Received May 13, 2010

    Report

    Report Number
    2026095-2010-00047
    Event Type
    Other
    Date Received
    May 13, 2010
    Date of Event
    July 6, 2006
    Report Date
    April 16, 2010
    Manufacturer
    I-FLOW CORPORATION
    Product Code
    BSO
    PMA / PMN Number
    K051401
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFO CONTAINED HEREIN IS BASED ON THE INFO PROVIDED BY THE INITIAL REPORTER AND MEDWATCH FORM 3500A RECEIVED DIRECTLY FROM THE CUSTOMER. THE DEVICE IS NOT AVAILABLE FOR EVALUATION AND INVESTIGATION. WITHOUT THE ACTUAL SAMPLE, A COMPLETE ANALYSIS CANNOT BE CONDUCTED. THE DEVICE HISTORY RECORD WAS REVIEWED FOR THE LOT AND ALL MANUFACTURING OPERATIONS WERE FOUND TO BE WITHIN SPECIFICATION. A REVIEW OF THE LOT HISTORY FOUND NO OTHER COMPLAINTS FOR CATHETER BREAKS FOR THE REPORTED LOT NUMBER. 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." ((B)(4)). ALSO, IN THE PT GUIDELINE INSERT, I-FLOW HAS PROVIDED CATHETER REMOVAL INSTRUCTIONS TO ENSURE SAFE REMOVAL ((B)(4)). IT IS WORTH NOTING THAT I-FLOW'S CATHETERS ARE MADE OF A NON-TOXIC, MEDICAL-GRADE MATERIAL THAT MEETS (B)(4) 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 INFO THAT IS PERTINENT TO THIS EVENT BECOMES AVAILABLE, I-FLOW WILL SUBMIT A FOLLOW-UP REPORT. ADDITIONAL INFO FROM THE USER FACILITY REPORT: (B)(6). (B)(4). ON-Q PAIN PUMP.

    Description of Event or Problem · 1

    ON-Q PAIN PUMP WAS PLACE IN PTS STERNAL AREA DURING CARDIAC BYPASS SURGERY (B)(6) 2006. RN DISCONTINUED ON-Q CATHETERS (B)(6) 2006, LEFT ON-Q PUMP CATHETER SHORTER THAN RIGHT ON-Q PUMP CATHETER - NO RESISTANCE MET PER CHART DOCUMENTATION. MD NOTIFIED BY RN MD SHOWN: ON-Q PUMP CATHETERS. OK TO DISPOSE OF PUMP CATHETERS NOTED IN CHART. CHEST X-RAY (B)(6) 2006 AT 0930 AM. PT SEEN BY SURGEON ON (B)(6) 2010. WE WERE NOTIFIED BY SURGEON (B)(6) 2010, OF REMOVAL OF APPROX. 8" CATHETER RETAINED IN PT. CHEST X-RAY (B)(6) 2010 PER SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-Q SILVERSOAKER CATHETER CATHETER BSO I-FLOW CORPORATION PM025 642484

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other| R TRIPLE LUMEN: RIGHT & LEFT CHEST TUBES| ARTERIAL LINE: SWAN GANZ CATHETER