BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ON-Q EXPANSION KITS WITH SOAKER CATHETER, 5 IN. (12.5 CM) / NEEDLE 6 IN X 17 G

    MDR report key: 11142799 · Received January 8, 2021

    Report

    Report Number
    2026095-2021-00006
    Event Type
    Malfunction
    Date Received
    January 8, 2021
    Date of Event
    December 7, 2020
    Report Date
    February 12, 2021
    Manufacturer
    AVANOS MEDICAL, INC.
    Product Code
    BSO
    UDI-DI
    10680651135343
    PMA / PMN Number
    K043456
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD FOR THE REPORTED LOT NUMBER, 20015344, IN THIS COMPLAINT WAS REVIEWED AND THE MATERIAL WAS PRODUCED ACCORDING TO THE MANUFACTURING PROCEDURES AND MET THE QUALITY REQUIREMENTS. ALL INFORMATION REASONABLY KNOWN AS OF 11-FEB-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. 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 COMP-GHC-20-03615. 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

    PROCEDURE: RADICAL LAPAROSCOPIC NEPHRECTOMY. PROCEDURE DATE: (B)(6) 2020. ADDITIONAL INFORMATION RECEIVED 20-JAN-2021 STATING THE CATHETER WAS NOT SUTURED, THIS WAS THE INITIAL INSERTION AT END OF CASE. THE CATHETER WAS INSERTED INTO SOFT TISSUE. THE DRUG WAS NOT A CONTRIBUTOR OR POTENTIAL CONTRIBUTOR TO THE REPORTED INCIDENT. .

    Additional Manufacturer Narrative · 1

    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 08-JAN-2020 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. 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: UNKNOWN. CATHPLACE: UNKNOWN. IT WAS REPORTED WHILE REMOVING THE SHEATH THE PHYSICIAN NOTICED THE TIP HAD COME OFF, ABOUT 2CM. THE PHYSICIAN HAD TO EXPLORE PART OF THE INCISION WHERE THE CATHETER WAS AND REMOVE THE TIP THAT BROKE OFF. THE CATHETER WAS REPLACED WITH A NEW ONQ CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37721 ON-Q EXPANSION KITS WITH SOAKER CATHETER, 5 IN. (12.5 CM) / NEEDLE 6 IN X 17 G KITS BSO AVANOS MEDICAL, INC. PM020 20015344 10680651135343

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR