BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ON Q PAINBUSTER

    MDR report key: 3233864 · Received July 12, 2013

    Report

    Report Number
    MW5030913
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Report Date
    July 12, 2013
    Manufacturer
    I-FLOW CORP
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD AN ON-Q 100ML ELASTOMERIC PAIN PUMP PLACED POST OPERATIVELY FILLED WITH 0.25% BUPIVACAINE. IT IS LABELLED TO INFUSE 1 ML/HR PER CATHETER. ONLY 1 CATHETER USED, OTHER CLAMPED OFF. SHOULD HAVE LASTED PATIENT 100 HOURS. THE DEVICE WAS COMPLETELY EMPTY IN 32 HOURS. NO ADVERSE EVENT REPORTED - SECOND ON-Q DEVICE DISPENSED WITH 100 ML. PATIENT REPORTED IT LASTED 4 DAYS AS EXPECTED. DATES OF USE: 1 DAY (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323683 ON Q PAINBUSTER ON Q PAINBUSTER MEB I-FLOW CORP PM0.9 0200946841

    Patients

    Seq Age Sex Outcome Treatment
    1