BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ON-Q PAIN SYSTEM WITH SILVERSOAKER CATHETER,100ML,2ML/HR

    MDR report key: 17483764 · Received August 8, 2023

    Report

    Report Number
    2026095-2023-00087
    Event Type
    Injury
    Date Received
    August 8, 2023
    Date of Event
    June 20, 2023
    Report Date
    October 30, 2023
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    MEB
    UDI-DI
    00193494136277
    PMA / PMN Number
    K063530
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD FOR THE REPORTED LOT NUMBER, 30194822, WAS REVIEWED AND DOCUMENTED THAT THE LOT WAS MANUFACTURED ACCORDING TO THE APPROVED MANUFACTURING PROCEDURES, SPECIFICATIONS, AND THEN RELEASED BY QUALITY ASSURANCE. ALL INFORMATION REASONABLY KNOWN AS OF 27-OCT-2023 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.

    Additional Manufacturer Narrative · 0

    THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD IS IN-PROGRESS. ALL INFORMATION REASONABLY KNOWN AS OF 07-AUG-2023 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

    AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT EVENTS. THIS IS THE SECOND OF TWO REPORTS. REFER TO 2026095-2023-00086 FOR THE FIRST EVENT. FILL VOLUME: UNKNOWN; FLOW RATE: UNKNOWN; PROCEDURE: UNKNOWN; CATHPLACE: UNKNOWN. IT WAS REPORTED THE "PUMP WAS REMOVED IN [A] HOSPITAL BEFORE DISCHARGED. THE WOUND SIDE HAD NO INFECTION. BUT WHEN PATIENT [TRAVELED], [THE PATIENT] REALIZED THAT [THE] WOUND WAS INFECTED...DID A CULTURE SWAB... AND IT WAS STAPH AUREUS." ADDITIONAL INFORMATION RECEIVED 24-JUL-2023 STATED THE PATIENT IS REPORTED TO BE WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2338904 ON-Q PAIN SYSTEM WITH SILVERSOAKER CATHETER,100ML,2ML/HR KITS MEB AVANOS MEDICAL INC. PS6502-A 30194822 00193494136277

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other MARCAINE 0.25