BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ON-Q PAIN RELIEF SYSTEM WITH SELECT-A-FLOW

    MDR report key: 16067800 · Received December 29, 2022

    Report

    Report Number
    16067800
    Event Type
    Malfunction
    Date Received
    December 29, 2022
    Date of Event
    November 19, 2022
    Report Date
    December 6, 2022
    Manufacturer
    AVANOS MEDICAL, INC.
    Product Code
    MEB
    UDI-DI
    00193494134723
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ONQ BUPIVACAINE 0.2% AT 10ML/HR DUE TO BE EMPTY AT 1830. PATIENT REPORTS ONQ EMPTY AT 0800. RATE REGULATOR SET AT 10ML/HR CHECKED BY PATIENT. INFUSION POSSIBLY RAN IN AT A FASTER RATE ENDING SOONER THAN ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2767096 ON-Q PAIN RELIEF SYSTEM WITH SELECT-A-FLOW PUMP, INFUSION, ELASTOMERIC MEB AVANOS MEDICAL, INC. 13472 30155153 00193494134723

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown