BEUDAMED
    FDA Adverse Event Other Summary report: N

    ON-Q PAINBUSTER

    MDR report key: 1930294 · Received November 24, 2010

    Report

    Report Number
    2026095-2010-00291
    Event Type
    Other
    Date Received
    November 24, 2010
    Date of Event
    September 25, 2010
    Report Date
    October 27, 2010
    Manufacturer
    I-FLOW CORP.
    Product Code
    MEB
    PMA / PMN Number
    K063530
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLE WILL BE SUBMITTED FOR THIS EVAL AND INVESTIGATION. THE IDENTIFICATION OF THE SEGMENT REMOVED FROM THE PT IS BASED ON THE USE OF ON-Q PRODUCTS BY THE FACILITY. THE SEGMENT IS BEING RETAINED BY THE FACILITY AT THIS TIME. THE REPORT INDICATED THAT NO PRODUCT FAILURE OCCURRED. WITHOUT THE ACTUAL PRODUCT OR A LOT NUMBER, A COMPLETE ANALYSIS CANNOT BE CONDUCTED. AS NO LOT NUMBER WAS PROVIDED, THE DEVICE HISTORY RECORD AND LOT HISTORY CANNOT BE REVIEWED. WITHOUT ADDITIONAL INFO ON THE PUMP AND/OR PT, NO FURTHER INVESTIGATION CAN BE PERFORMED. THE DIRECTIONS FOR USE (1306078, REV. D) STATES: "WHILE HOLDING CATHETER TIP, WITHDRAW SHEATH COMPLETELY FROM PUNCTURE SITE PRIOR TO SPLITTING TO AVOID SHEATH BREAKING OFF IN PT. SPLIT SHEATH AND PEEL AWAY FROM CATHETER." A WARNING IS ALSO INCLUDED, STATING "DO NOT REINSERT A PARTIALLY OR COMPLETELY WITHDRAWN NEEDLE AS THIS CAN DAMAGE THE SHEATH AND BREAK OFF IN PT UPON SHEATH REMOVAL." NO DETERMINATION CAN BE MADE AS TO WHAT MAY HAVE OCCURRED WITH THIS PRODUCT AT THIS TIME.

    Description of Event or Problem · 1

    THE PHYSICIAN SURGICALLY REMOVED A PIECE OF SHEATH ACCIDENTALLY LEFT IN THE PT DURING A PREVIOUS SURGERY ON (B)(6) 2010. IT WAS REPORTED THAT THERE WAS NO PRODUCT FAILURE. VISIBLE EVIDENCE OF NEEDLE INTO SHEATH, SO IT SHEARED OFF. SAMPLE BEING RETAINED BY FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-Q PAINBUSTER INFUSION PUMP MEB I-FLOW CORP. PM028-A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other