BEUDAMED
    FDA Adverse Event Other Summary report: N

    ON-Q PAINBUSTER

    MDR report key: 1053027 · Received May 27, 2008

    Report

    Report Number
    2026095-2008-00066
    Event Type
    Other
    Date Received
    May 27, 2008
    Date of Event
    April 24, 2008
    Report Date
    April 28, 2008
    Manufacturer
    I-FLOW CORP.
    Product Code
    MEB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NURSE

    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. IT WAS REPORTED THAT DURING REMOVAL OF THE CATHETER BY THE SURGEON, THE CATHETER STRETCHED AND BROKE INSIDE THE PT, LEAVING ABOUT 8CM INSIDE THE PT. ADD'L SURGERY WAS REQUIRED TO REMOVE THE REMAINING SEGMENT. BASED ON THE INFO PROVIDED, THE PUMP REPORTED IS NOT SOLD WITH A CATHETER. IT IS NOT KNOWN IF AN I-FLOW CATHETER WAS USED. FOLLOW-UP INVESTIGATION CONTINUES. WHEN ADD'L INFO THAT IS PERTINENT TO THIS EVENT BECOMES AVAILABLE, I-FLOW WILL REOPEN THE COMPLAINT.

    Description of Event or Problem · 1

    CATHETER BROKE DURING REMOVAL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention