BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNK

    MDR report key: 1579924 · Received January 8, 2010

    Report

    Report Number
    2026095-2009-00299
    Event Type
    Other
    Date Received
    January 8, 2010
    Date of Event
    June 1, 2006
    Report Date
    December 9, 2009
    Manufacturer
    I-FLOW CORP.
    Product Code
    BSO
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THIS INCIDENT WAS NOT AVAILABLE FOR EVALUATION AND INVESTIGATION. WITHOUT THE ACTUAL PRODUCT, PART NUMBER, OR LOT NUMBER, A COMPLETE ANALYSIS CANNOT BE CONDUCTED. THE ACTUAL DEVICE HAS BEEN RETAINED AT THE FACILITY. BASED ON THIS INFO RECEIVED, THE TECHNIQUE USED IN THE REMOVAL OF THE CATHETER MOST LIKELY CONTRIBUTED TO THE REPORTED INCIDENT. AS NO LOT NUMBER WAS PROVIDED, THE DEVICE HISTORY RECORD AND LOT HISTORY CANNOT BE REVIEWED. 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). 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 ADD'L INFO THAT IS PERTINENT TO THIS EVENT BECOMES AVAILABLE, I-FLOW WILL SUBMIT A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    ON (B)(6) 2006, A PT HAD SURGERY PERFORMED FOR A CIRCUM. ABDOMINOPLASTY AFTER GASTRIC BYPASS SURGERY. AN ON-Q PUMP WAS PLACED WITH DUAL CATHETERS PLACED IN THE LEFT FLANK OF THE PT. FROM MEDICAL RECORDS, IT APPEARED THAT THE PT HAD NO SPECIFIC MEDICAL ISSUES UNTIL (B)(6) 2009, WHEN HE EXPERIENCED CHRONIC DRAINAGE FROM THE CATHETER SITE. A PHYSICAL EXAM FELT A MASS ON (B)(6) 2009. THE PT WAS TAKEN TO SURGERY AND THE MASS WAS REMOVED. THE PATHOLOGY REPORT FOUND, AMONG OTHER THINGS, TWO 0.1CM DIAMETER X 11.0 AND 14.0CM LENGTHS OF PLASTIC COVERED WIRE WITH MINIMAL ADHERENCE OF BLOOD AND NO ADHERENCE OF TISSUE. THIS WAS PRESUMED TO BE THE CATHETERS THAT WERE PLACED IN 2006. SAMPLES WERE RETAINED BY VAMC. PHOTOGRAPHS WERE SENT. IT WAS STATED THAT THE PT IS DOING WELL AND WAS DISCHARGED (B)(6) 2009.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK CATHETER BSO I-FLOW CORP. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention