BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ON-Q PAIN RELIEF SYSTEM WITH SILVERSOAKER ANTIMICROBIAL CATHETER, 100 ML X 2 ML

    MDR report key: 10148889 · Received June 12, 2020

    Report

    Report Number
    2026095-2020-00100
    Event Type
    Malfunction
    Date Received
    June 12, 2020
    Date of Event
    May 15, 2020
    Report Date
    June 12, 2020
    Manufacturer
    AVANOS MEDICAL - IRVINE
    Product Code
    MEB
    UDI-DI
    00193494137229
    PMA / PMN Number
    K063530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD FOR THE REPORTED LOT NUMBER, 0203022133, IN THIS COMPLAINT WAS REVIEWED AND THE MATERIAL WAS PRODUCED ACCORDING TO THE MANUFACTURING PROCEDURES AND MET THE QUALITY REQUIREMENTS. THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. ALL INFORMATION REASONABLY KNOWN AS OF 11-JUN-2020 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. 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).

    Description of Event or Problem · 1

    FILL VOLUME: UNKNOWN. FLOW RATE: UNKNOWN. PROCEDURE: LEFT FOOT BUNIONECTOMY. CATHPLACE: LEFT FOOT. DATE PROCEDURE: (B)(6) 2020. IT WAS REPORTED AN ON-Q CATHETER KINKED. THE SURGEON WAS UNABLE TO REMOVE THE CATHETER IN THE OFFICE. THE PATIENT REQUIRED A RETURN VISIT TO THE OPERATING ROOM TO HAVE THE CATHETER REMOVED. WHILE THE CATHETER WAS IN PLACE THE PATIENT'S PAIN WAS "WELL CONTROLLED" AND "THE BALL LOOKED LIKE IT INFUSED THE MEDICATION." THE CATHETER WAS REMOVED IN SURGICAL SETTING AND NOTED TO BE IN TWO PIECES. THE PATIENT WAS DISCHARGED HOME IN STABLE CONDITION. THERE WAS NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612838 ON-Q PAIN RELIEF SYSTEM WITH SILVERSOAKER ANTIMICROBIAL CATHETER, 100 ML X 2 ML CATHETERS MEB AVANOS MEDICAL - IRVINE PM032-A 0203022133 00193494137229

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR