BEUDAMED
    FDA Adverse Event Other Summary report: N

    ON-Q SILVERSOAKER

    MDR report key: 1438469 · Received October 24, 2008

    Report

    Report Number
    2026095-2008-00177
    Event Type
    Other
    Date Received
    October 24, 2008
    Date of Event
    September 26, 2008
    Report Date
    September 26, 2008
    Manufacturer
    I-FLOW CORP.
    Product Code
    MEB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFO CONTAINED HEREIN IS BASED ON THE INFO PROVIDED BY THE INITIAL REPORTER. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. BASED ON THIS INFO RECEIVED, THE TECHNIQUE USED BY THE NURSE IN THE REMOVAL OF THE CATHETER MOST LIKELY CONTRIBUTED TO THE REPORTED INCIDENT. A REVIEW OF THE LOT HISTORY INDICATED THAT IT WAS THE ONLY COMPLAINT FOR CATHETER BREAKAGE FOR THIS LOT. THE DEVICE HISTORY RECORD WAS ALSO REVIEWED, AND ALL MANUFACTURING OPERATIONS WERE FOUND TO BE WITHIN SPECIFICATION. IN THE PT 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 SYS". IT IS WORTH NOTHING THAT I-FLOW'S CATHETERS ARE MADE OF A NON-TOXIC, MEDICAL-GRADE MATERIAL THAT MEETS ISO (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 PERTINENT TO THIS EVENT BECOMES AVAILABLE, I-FLOW WILL SUBMIT A FOLLOW-UP REPORT. ADDITIONAL INFO FROM VOLUNTARY REPORT: (B) (4). EVENT DATE: (B) (6) 2008: ON Q PAIN BUSTER-POST OP PAIN RELIEF SYS. (B) (6): ALSO REPORTED TO: MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NURSE PULLED OUT THE CATHETER CAUSING IT TO STRETCH AND BREAK. IT WAS STATED THAT THE NURSE WAS UNFAMILIAR WITH THE ON-Q PRODUCT. FOLLOW-UP WITH THE HOSP INDICATED THAT APPROXIMATELY 6 OR 7 INCHES OF THE CATHETER REMAINED INSIDE THE PT AND WAS SURGICALLY REMOVED IN THE OPERATING ROOM ON (B) (6) 2008. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. ADDITIONAL INFO FROM THE VOLUNTARY REPORT: ONQ PUMP CATHETER WAS REMOVED ON (B) (6) 2008 AND A PORTION OF THE CATHETER WAS LEFT INSIDE THE OPERATIVE AREA. THE PT HAD TO RETURN TO OR ON (B) (6) 2008 FOR THE REMOVAL OF THE RETAINED PORTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-Q SILVERSOAKER INFUSION PUMP MEB I-FLOW CORP. PM025-A 832493

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Hospitalization| O| R