BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIC GASTROSTOMY FEEDING TUBE WITH ENFIT CONNECTORS - 14 FR

    MDR report key: 12143120 · Received July 9, 2021

    Report

    Report Number
    9611594-2021-00092
    Event Type
    Injury
    Date Received
    July 9, 2021
    Date of Event
    June 14, 2021
    Report Date
    July 9, 2021
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KNT
    UDI-DI
    00350770442914
    PMA / PMN Number
    K842076
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. THE DEVICE HISTORY RECORD FOR THE REPORTED LOT NUMBER, 30122660, 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 08-JUL-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).

    Description of Event or Problem · 1

    IT WAS REPORTED THE GASTRIC PLUG WOULD NOT REMAIN CLOSED ON THE DEVICE. THE FAMILY MEMBER STATED, "ALMOST IMMEDIATELY" AFTER PLACEMENT THE GASTRIC PLUG ON THE MIC-G TUBE WILL NOT REMAIN CLOSED. THE GASTRIC LEAKAGE CAUSED THE SKIN TO BECOME IRRITATED. MUPIROCIN AND CALMOSEPTINE OINTMENT WERE PRESCRIBED TO TREAT THE SKIN IRRITATION. THERE WAS NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1041632 MIC GASTROSTOMY FEEDING TUBE WITH ENFIT CONNECTORS - 14 FR DH EF BALLOON TUBES PRODUCTS KNT AVANOS MEDICAL INC. 8100-14LV 30122660 00350770442914

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Other