BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HALYARD HEALTH

    MDR report key: 6553811 · Received May 5, 2017

    Report

    Report Number
    MW5069628
    Event Type
    Malfunction
    Date Received
    May 5, 2017
    Date of Event
    April 10, 2017
    Report Date
    April 25, 2017
    Manufacturer
    HALYARD HEALTH GLOBAL HEADQUARTERS
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OR, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    ON-Q PUMP WAS FILLED WITH ROPIVACAINE DILUTED TO 0.2% PER PROCEDURE ON (B)(6) 2017. WHEN PUMP WAS DISPENSED, IT WAS LEAKING PROFUSELY WHERE THE TUBING CONNECTS TO THE DEVICE. THIS WAS DISCOVERED PRIOR TO DISPENSING TO A PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331120 HALYARD HEALTH ON-Q ELASTOMERIC PUMP W/ SELECT-A-FLOW MEB HALYARD HEALTH GLOBAL HEADQUARTERS 0202610720

    Patients

    Seq Age Sex Outcome Treatment
    1