BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ON-Q C-BLOC WITH ONDEMAND

    MDR report key: 833369 · Received March 27, 2007

    Report

    Report Number
    MW1042370
    Event Type
    Malfunction
    Date Received
    March 27, 2007
    Report Date
    March 27, 2007
    Manufacturer
    I-FLOW CORPORATION
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    REGARDING ON-Q C-BLOC WITH ONDEMAND PAIN PUMP -REF CB003; PART NO. 5001438; MANUFACTURED BY I-FLOW CORP-. THE BOLUS PART OF THE PUMP, USED BY THE PT TO DELIVER A 5ML BOLUS OF MEDICATION, WILL SOMETIMES JAM RENDERING THAT PIECE OF THE MEDICAL DEVICE USELESS. IT HAS HAPPENED BOTH DURING PREPARATION BY PHARMACY DURING PRIMING OF THE PUMP AS WELL AS AFTER DELIVERY FOR USE BY THE PT. DIAGNOSIS FOR USE: CONTINUOUS NERVE BLOCK POST SURGERY. DATE OF USE: 08/01/06- 03/27/07.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-Q C-BLOC WITH ONDEMAND * MEB I-FLOW CORPORATION CB003 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *