BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIC-KEY LOW-PROFILE GASTROSTOMY FEEDING TUBE - 20 FR, 2.5 CM

    MDR report key: 12297875 · Received August 9, 2021

    Report

    Report Number
    9611594-2021-00100
    Event Type
    Malfunction
    Date Received
    August 9, 2021
    Date of Event
    July 12, 2021
    Report Date
    September 20, 2021
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KNT
    PMA / PMN Number
    K993138
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT INVOLVED IN THE REPORT HAS BEEN RETURNED AND IS BEING PROCESSED FOR EVALUATION. ALL INFORMATION REASONABLY KNOWN AS OF 18-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). 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 DEVICE HISTORY RECORD FOR THE REPORTED LOT NUMBER, 30117976, WAS REVIEWED AND DOCUMENTED THAT THE LOT WAS MANUFACTURED ACCORDING TO THE APPROVED MANUFACTURING PROCEDURES, SPECIFICATIONS, AND THEN RELEASED BY QUALITY ASSURANCE. ONE USED SAMPLE WAS RECEIVED. NO PRODUCT PACKAGING WAS RECEIVED WITH THE SAMPLE. THE SAMPLE WAS EXAMINED. THE SAMPLE WAS OBSERVED TO HAVE THE TUBE CUT OR TORN JUST DISTAL OF THE MOLDED HEAD BOTTOM COLLAR. THE DISTAL PORTION OF THE TUB AND BALLOON WERE NOT RETURNED WITH THE SAMPLE. THE SAMPLE TUBE WAS OBSERVED TO BE CUT OR TORN AT AN ANGLE ACROSS THE TUBE JUST DISTAL OF THE MOLDED HEAD BOTTOM COLLAR. THERE WERE TWO SMALL AREAS THAT APPEARED TO BE ADHESIVE OR SMALL SCUFF MARKS ON THE MOLDED HEAD COLLAR ON THE FRENCH SIZE SIDE JUST PROXIMAL OF THE TUBE CUT OR TEAR. ROOT CAUSE COULD NOT BE DETERMINED. ALL INFORMATION REASONABLY KNOWN AS OF 17-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 (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 DEVICE IS REPORTED TO BE AVAILABLE BUT HAS NOT BEEN RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD IS IN-PROGRESS. ALL INFORMATION REASONABLY KNOWN AS OF 09-AUG-2021 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. 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 GASTROSTOMY TUBE WAS CUT OFF AT THE SHAFT. THERE WAS A POSSIBILITY THAT A PATIENT CUT IT OFF...THE BALLOON SIDE WAS LEFT IN THE PATIENT AND IT ALREADY WENT TO SMALL INTESTINE, SO A DOCTOR IS WAITING UNTIL IT IS EXCRETED. IT WAS CONFIRMED THAT THE BALLOON WAS DEFLATED BEFORE THE TUBE WAS CUT OFF."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1192546 MIC-KEY LOW-PROFILE GASTROSTOMY FEEDING TUBE - 20 FR, 2.5 CM DH EF BALLOON TUBES PRODUCTS KNT AVANOS MEDICAL INC. 0620-20-2.5 30117976

    Patients

    Seq Age Sex Outcome Treatment
    1