BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-FLOW CORPORATION

    MDR report key: 1842652 · Received September 20, 2010

    Report

    Report Number
    MW5017509
    Event Type
    Malfunction
    Date Received
    September 20, 2010
    Date of Event
    September 7, 2010
    Report Date
    September 9, 2010
    Manufacturer
    KIMBERLY CLARK, I-FLOW CORP.
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    MD ATTEMPTED TO REMOVE ON-Q PUMP AND WAS UNSUCCESSFUL. OTHER MD WAS CALLED IN TO ATTEMPT REMOVAL AND IN PROCESS CATHETER "SNAPPED OFF" WITH PART OF TUBING STILL IN PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 I-FLOW CORPORATION ON-Q PAINBUSTER POST-OP PAIN RELIEF SYSTEM MEB KIMBERLY CLARK, I-FLOW CORP. 042773

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR