BEUDAMED
    FDA Adverse Event Other Summary report: N

    ON-Q PAINBUSTER SOAKER

    MDR report key: 1200217 · Received October 1, 2008

    Report

    Report Number
    2026095-2008-00165
    Event Type
    Other
    Date Received
    October 1, 2008
    Date of Event
    August 28, 2008
    Report Date
    September 2, 2008
    Manufacturer
    I-FLOW CORP.
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION CONTAINED HEREIN IS BASED ON THE INFORMATION PROVIDED BY THE INITIAL REPORTER AND THE EVALUATION OF THE SAMPLE. ONE PARTIAL CATHETER WAS RECEIVED FOR EVALUATION AND INVESTIGATION. VISUAL INSPECTION OF THE CATHETER FOUND THAT THE INFUSION SEGMENT OF THE CATHETER WAS OVERSTRETCHED, AND THE TIP AND PART OF THE INFUSION SEGMENT OF THE CATHETER WAS NOT RECEIVED. IN ADDITION, RETAINED DEVICES FROM LOT NO. 822297 WERE TESTED AND REVEALED THAT THE TENSILE STRENGTH WAS WITHIN SPECIFICATION. BASED ON THIS INFORMATION RECEIVED AND THE EVALUATION OF THE CATHETER RECEIVED, THE TECHNIQUE USED IN THE REMOVAL OF THE CATHETER MOST LIKELY CONTRIBUTED TO THE REPORTED INCIDENT. THE LOT HISTORY WAS REVIEWED AND THIS WAS FOUND TO BE THE ONLY COMPLAINT FOR THIS LOT. THE DEVICE HISTORY RECORD WAS ALSO REVIEWED, AND ALL MANUFACTURING OPERATIONS WERE FOUND TO BE WITHIN SPECIFICATION. IN THE PATIENT GUIDELINE INSERT, I-FLOW HAS PROVIDED CATHETER REMOVAL INSTRUCTIONS TO ENSURE SAFE REMOVAL. 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." IT IS WORTH NOTHING THAT I-FLOW'S CATHETERS ARE MADE OF A NON-TOXIC, MEDICAL-GRADE MATERIAL THAT MEETS ISO 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'S WIFE FELT RESISTANCE DURING CATHETER REMOVAL AND THINKS THAT THE CATHETER MAY HAVE TORN. THE BLACK TIP WAS NOT SEEN AT THE END OF THE CATHETER. IT WAS STATED THAT THE PATIENT WAS STABLE AND NO INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-Q PAINBUSTER SOAKER INFUSION PUMP MEB I-FLOW CORP. PM012 822297

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other