BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRODUCER KIT FOR GASTRO-FEEDING TUBE, 24FR DILATOR

    MDR report key: 16598468 · Received March 23, 2023

    Report

    Report Number
    9611594-2023-00041
    Event Type
    Malfunction
    Date Received
    March 23, 2023
    Report Date
    March 23, 2023
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KGC
    UDI-DI
    10680651984347
    PMA / PMN Number
    K080253
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD IS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. ROOT CAUSE COULD NOT BE DETERMINED. ALL INFORMATION REASONABLY KNOWN AS OF 22-MAR-2023 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). 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

    IT WAS REPORTED THE "BARS MIGRATED. NO INJURY NOR MEDICAL INTERVENTION. THE T-BARS WERE PLACED IN (B)(6) 2022. (ABOUT 6 MONTHS AGO) IT WAS FOUND IN THE PROCESS OF MRT (MAGNETIC RESONANCE TEST) OR CT (COMPUTED TOMOGRAPHY). NO INJURY NOR MEDICAL INTERVENTION." ADDITIONAL INFORMATION RECEIVED 01-MAR-2023 STATED IT IS UNKNOWN AS TO WHY THE CT/ MRT WAS PERFORMED BUT IT WAS NOT DUE TO THE PATIENT'S WORSENED CONDITION. THE LOCATION OF THE T-BARS ON THE CT/MRT WAS NOTED TO BE SOMEWHERE BETWEEN GASTRIC WALL AND ABDOMINAL WALL. IT APPEARED THE T-BAR REMAINED IN THE LOCATION FOR A WHILE OR SINCE THE FIRST PLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10841 INTRODUCER KIT FOR GASTRO-FEEDING TUBE, 24FR DILATOR DH EF PERC PLACEMENT PRODUCTS KGC AVANOS MEDICAL INC. 98434 NOT PROVIDED 10680651984347

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown