BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ON-Q PAIN RELIEF SYSTEM WITH SAF, 400 ML, 2-14 ML/HR

    MDR report key: 24876453 · Received April 14, 2026

    Report

    Report Number
    2026095-2026-00029
    Event Type
    Malfunction
    Date Received
    April 14, 2026
    Report Date
    April 14, 2026
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    MEB
    UDI-DI
    00193494134723
    PMA / PMN Number
    K063530
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ACTUAL COMPLAINT PRODUCT WAS RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD AND UDI NUMBER ARE IN-PROGRESS. ALL INFORMATION REASONABLY KNOWN AS OF 14-APR-2026 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY AVANOS MEDICAL, INC. REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO AVANOS MEDICAL, INC. AVANOS MEDICAL, INC. HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE AVANOS MEDICAL, INC. COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN AVANOS MEDICAL, INC. PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY.

    Description of Event or Problem · 0

    FILL VOLUME: 550 ML. FLOW RATE: 8 ML/HR. PROCEDURE: LEFT KNEE SURGERY. CATHPLACE: UNKNOWN. IT WAS REPORTED THE PATIENT HAD A SEVERE REACTION. THE PUMP WAS "SET TO 8ML/HE SO NOT SURE IF IT WAS INFUSING AT AN APPROPRIATE RATE OR NOT. APPEARS TO HAVE NO ISSUE BUT WANT TO CHECK FLOW TO MAKE SURE THERE WAS NO ISSUE WITH FLOW RATE." THE PATIENT EXPERIENCED SEIZURE AND HYPOTENSION. INTERVENTION ENTAILED INTUBATION FOR AIRWAY PROTECTION. ROPIVACAINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    938668 ON-Q PAIN RELIEF SYSTEM WITH SAF, 400 ML, 2-14 ML/HR ELASTOMERIC - SAF MEB AVANOS MEDICAL INC. CB004 20130522 00193494134723

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Male Other ROPIVACAINE.