BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ON-Q* C-BLOC PAIN RELIEF SYSTEM

    MDR report key: 17641207 · Received August 29, 2023

    Report

    Report Number
    17641207
    Event Type
    Malfunction
    Date Received
    August 29, 2023
    Date of Event
    June 27, 2023
    Report Date
    July 11, 2023
    Manufacturer
    AVANOS MEDICAL, INC.
    Product Code
    MEB
    UDI-DI
    00193494134693
    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

    PATIENT REPORTED SEVERE PAIN ALL NIGHT AND DID NOT THINK ON-Q PUMP WAS WORKING. PATIENT DID NOT SEE ANY KINKS IN THE TUBING AND THE TUBING IS NOT CLAMPED. HAD PATIENT DISCONNECT THE TUBING FROM THE CATHETER WITH HELP FROM THE FAMILY AND THEY DID NOT SEE ANYTHING DRIPPING FROM THE END OF THE ON-Q TUBING. ON-Q PUMP HAS NOT DECREASED IN SIZE SINCE CONNECTION YESTERDAY. PATIENT WAS INSTRUCTED TO REMOVE THE NERVE CATHETER AND REPORT HER LACK OF PAIN CONTROL TO HER SURGICAL TEAM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2082390 ON-Q* C-BLOC PAIN RELIEF SYSTEM PUMP, INFUSION, ELASTOMERIC MEB AVANOS MEDICAL, INC. CB002 QS-33788 00193494134693

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown