BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ON-Q* PAIN RELIEF SYSTEM

    MDR report key: 21772749 · Received April 4, 2025

    Report

    Report Number
    21772749
    Event Type
    Malfunction
    Date Received
    April 4, 2025
    Date of Event
    March 23, 2025
    Report Date
    March 25, 2025
    Manufacturer
    AVANOS MEDICAL, INC.
    Product Code
    MEB
    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 HAD AN ON-Q PUMP PLACED. ON PATIENT'S FIFTH POST OP DAY, THE RN [REGISTERED NURSE] ASSESSING THE ON-Q PUMP OBSERVED THAT THE ON-Q PUMP'S OUTER SHELL HAD DEFLATED AS IT SHOULD; HOWEVER, DEFLATED THE INNER TUBE HAD A LARGE "BALLOON" OR BULGE COMING OFF THE INSIDE TUBE. THE RN REPORTED NEVER HAVING OBSERVED THIS OCCURRING BEFORE. THE RN CALLED PHARMACY, SURGERY AND PACU [POST ANESTHESIA RECOVERY UNIT] AND THEY HAD NO GUIDANCE THEY COULD OFFER. THE RN CALLED REPRESENTATIVE LINE LISTED ON THE ON-Q PUMP BROCHURE FOR PATIENT USE. SPOKE TO REP ON PHONE, SENT THEM PUMP INFORMATION AND WILL BE SENDING THE PUMP BACK TO COMPANY FOR REVIEW. THE REP. REPORTED BOT HAVING SEEN THIS HAPPEN BEFORE EITHER. PATIENT HAS NOT HAD ISSUES WITH PAIN RELIEF NOR ANY COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2323414 ON-Q* PAIN RELIEF SYSTEM PUMP, INFUSION, ELASTOMERIC MEB AVANOS MEDICAL, INC. 30264703

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Female