BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAPAROSCOPIC INTRODUCER KIT FOR GASTROSTOMY FEEDING TUBE, 22 FR DILATOR

    MDR report key: 12360338 · Received August 24, 2021

    Report

    Report Number
    9611594-2021-00111
    Event Type
    Injury
    Date Received
    August 24, 2021
    Date of Event
    July 25, 2021
    Report Date
    September 29, 2021
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KGC
    UDI-DI
    00350770102375
    PMA / PMN Number
    K080253
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD FOR THE REPORTED LOT NUMBER, 30063819, 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 28-SEP-2021 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-(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 · 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 23-AUG-2021 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). THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE T-FASTENERS WERE BROKEN AND MISSING CAUSING THE PATIENT PERITONITIS DUE TO TUBE MIGRATION WHILE BEING HOSPITALIZED FOR MULTISYSTEM TRAUMA RECEIVED FROM A PEDESTRIAN/AUTOMOBILE ACCIDENT. THE PATIENT WAS THE PEDESTRIAN INVOLVED IN THE ACCIDENT. INITIAL HOSPITALIZATION REQUIRED PATIENT ADMISSION TO THE ICU FOR TREATMENT AND INTUBATION TO MAINTAIN AIRWAY. ON (B)(6) 2021 THE PATIENT'S FEEDING TUBE WAS PLACED USING AN INTRODUCER KIT. THE "CORRECT" TUBE PLACEMENT WAS CONFIRMED VIA ESOPHAGOGASTRODUODENOSCOPY (EGD) VISUALIZATION. ON (B)(6) 2021 THE PATIENT RETURNED TO THE OPERATING ROOM (OR) FOR AN EMERGENCY EXPLORATORY LAP DUE TO WORSENING CONDITION. DURING THE PROCEDURE IT WAS DISCOVERED THAT TWO T-FASTENERS WERE BROKEN AND TWO T-FASTENERS WERE MISSING CAUSING THE TUBE TO MIGRATE. THREE LITERS OF ENTERAL FEEDING SOLUTION WAS REMOVED FROM THE PATIENT'S ABDOMINAL CAVITY. THE PATIENT CURRENTLY REMAINS INTUBATED AND IN STABLE BUT CRITICAL CONDITION IN THE INTENSIVE CARE UNIT (ICU) FOR TREATMENT OF MULTISYSTEM TRAUMA CAUSED BY PEDESTRIAN/AUTOMOBILE ACCIDENT, FURTHER COMPLICATED BY THE DIAGNOSIS OF PERITONITIS. THE PATIENT'S PERITONITIS IS BEING TREATED WITH INTRAVENOUS (IV) ANTIBIOTICS. THE USER REPORTS A MEDSUN REPORT WAS FILED ON 29-JUL-2021, BUT THE MEDSUN REPORT NUMBER WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1257645 LAPAROSCOPIC INTRODUCER KIT FOR GASTROSTOMY FEEDING TUBE, 22 FR DILATOR DH EF PERC PLACEMENT PRODUCTS KGC AVANOS MEDICAL INC. 10237 30063819 00350770102375

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention