BEUDAMED
    FDA Adverse Event Other Summary report: N

    ON-Q PAINBUSTER

    MDR report key: 821921 · Received February 13, 2007

    Report

    Report Number
    2026095-2007-00010
    Event Type
    Other
    Date Received
    February 13, 2007
    Date of Event
    January 1, 2007
    Report Date
    February 1, 2007
    Manufacturer
    I-FLOW CORP.
    Product Code
    MEB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE DEVICE INVOLVED IN THIS INCIDENT WAS NOT AVAILABLE FOR EVALUATION. WITHOUT THE ACTUAL PRODUCT, A COMPLETE ANALYSIS CANNOT BE CONDUCTED. HOWEVER, WE TESTED TWO RETAIN CATHETERS HAVING THE SAME LOT NUMBER (672896) INVOLVED IN THIS INCIDENT. THE TENSILE STRENGTH OF THE "MID-BODY" AND "INFUSION" SEGMENT WAS TESTED, AND THE RESULTS WERE FOUND TO BE WITHIN ACCEPTABLE LIMITS. IN ADDITION, A REVIEW OF LOT HISTORY SHOWED THAT THIS WAS THE ONLY CATHETER BREAK RELATED INCIDENT FROM THIS LOT. WE ALSO REVIEWED THE DEVICE HISTORY RECORD OF THIS LOT, AND THE RECEIVING INSPECTION RECORD SHOWED THAT CATHETER TENSILE STRENGTH WAS TESTED AND FOUND TO BE WITHIN THE LIMIT. WE HAVE CONDUCTED AN INVESTIGATION ON PREVIOUS CATHETER BREAK INCIDENTS IN ORDER TO SHOW WHETHER THE CATHETER BREAKS ARE OCCURRING WITHIN THE ESTIMATED RISKS LIMITS OR NOT. THE CATHETER BREAK FAILURE RATE WAS CALCULATED SINCE 2003 BY DIVIDING THE NUMBER OF TOTAL CATHETER BREAKS OVER THE TOTAL NUMBER OF CATHETERS SHIPPED, AND IT WAS FOUND THAT THE CATHETER BREAKS ARE OCCURRING WITHIN THE ESTIMATED RISKS LIMITS. I-FLOW HAS PREPARED SEVERAL CATHETER PLACEMENT GUIDES FOR DIFFERENT SURGICAL PROCEDURES, AND A TECHNICAL BULLETIN IN ORDER TO PREVENT AND DECREASE CATHETER BREAKS. PLEASE SEE THE ATTACHED TECHNICAL BULLETIN 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 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.

    Description of Event or Problem · 1

    POST EAR RECONSTRUCTION, THE CATHETER BROKE WHILE BEING REMOVED IN 2007. THE FRAGMENT WAS SUBSEQUENTLY REMOVED TWO DAYS LATER, FROM ILIAC CREST BONE GRAFT SITE. THE PATIENT WAS REPORTED AS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-Q PAINBUSTER INFUSION PUMP MEB I-FLOW CORP. PM014 672896

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other