BEUDAMED
    FDA Adverse Event Other Summary report: N

    ON-Q PAINBUSTER

    MDR report key: 1061707 · Received June 13, 2008

    Report

    Report Number
    2026095-2008-00072
    Event Type
    Other
    Date Received
    June 13, 2008
    Date of Event
    April 1, 2008
    Report Date
    May 19, 2008
    Manufacturer
    I-FLOW CORP.
    Product Code
    MEB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE DEVICE INVOLVED IN THIS COMPLAINT WAS NOT AVAILABLE FOR EVAL. THE INFO CONTAINED HEREIN IS BASED ON THE INFO PROVIDED BY THE INITIAL REPORTER. THE INFO PROVIDED INDICATED THAT TWO PTS DEVELOPED INFECTIONS AFTER THE USE OF THE ON-Q PUMP. NO OTHER INFO WAS MADE AVAILABLE. ALL I-FLOW PRODUCTS ARE STERILIZED AND SEALED IN APPROPRIATE PACKAGING, TO BE OPENED ONLY IN A STERILE ENVIRONMENT BY INDIVIDUALS TRAINED IN STERILE PROCEDURE. PRIOR TO RELEASE, ALL PRODUCTION LOTS ARE SUBJECTED TO STRINGENT LAB TESTING TO ASSURE STERILITY. WITH THE ASSUMPTION THAT THE DEVICE WAS PROPERLY HANDLED BY THE CLINICAL PERSONNEL ASSOCIATED WITH THE SURGERY, THE DEVICE WAS INTRODUCED TO THE SURGICAL SITE IN A STERILE CONDITION. ANY INFECTION COMPLICATION FOLLOWING THEREAFTER IS MOST LIKELY DUE TO OTHER POSTOPERATIVE FACTORS. IF ADD'L INFO THAT IS PERTINENT TO THIS EVENT BECOMES AVAILABLE, I-FLOW WILL REOPEN THE COMPLAINT.

    Description of Event or Problem · 1

    TWO PTS DEVELOPED INFECTIONS AT THE CATHETER SITE AFTER USING ON-Q.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-Q PAINBUSTER INFUSION PUMP MEB I-FLOW CORP. PM026 7C2003

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Other