BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ON Q

    MDR report key: 6686046 · Received July 5, 2017

    Report

    Report Number
    6686046
    Event Type
    Malfunction
    Date Received
    July 5, 2017
    Date of Event
    June 2, 2017
    Report Date
    June 12, 2017
    Manufacturer
    HALYARD HEALTH, INC.
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    ID, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PATIENT RECEIVED AN ON-Q PAIN PUMP THAT MALFUNCTIONED AND "EXPLODED" OR LEAKED CONTENTS RENDERING PATIENT UNABLE TO RECEIVE PAIN BLOCKADE FOR THE 12 HOURS THEY SHOULD HAVE RECEIVED IT. MANUFACTURER RESPONSE FOR RA PUMP KITS SELECT A FLOW, ON Q RA PUMP KITS SELECT A FLOW (PER SITE REPORTER): SUPPORTIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    467794 ON Q PUMP, INFUSION, ELASTOMERIC MEB HALYARD HEALTH, INC. 202628360

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR OTHER, ADDITIONAL PAIN PUMP DELIVERED