BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRODUCER KIT FOR GASTROSTOMY FEEDING TUBE

    MDR report key: 21741432 · Received April 1, 2025

    Report

    Report Number
    9611594-2025-00072
    Event Type
    Malfunction
    Date Received
    April 1, 2025
    Date of Event
    March 5, 2025
    Report Date
    October 9, 2025
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KGC
    PMA / PMN Number
    K080253
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D9, H3, H6. THE PRODUCT INVOLVED IN THE REPORT HAS BEEN RETURNED AND THE INVESTIGATION REMAINS IN PROGRESS AT THIS TIME. ALL INFORMATION REASONABLY KNOWN AS OF 05 MAY 2025 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 REPORTED EVENT BUT IS RELAYING THE INFORMATION PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE AVANOS MEDICAL 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 SAMPLE IS REPORTED TO BE AVAILABLE BUT HAS NOT YET BEEN RECEIVED BY THE MANUFACTURER. A REVIEW OF THE DEVICE HISTORY RECORD AND UDI ARE IN-PROGRESS. ALL INFORMATION REASONABLY KNOWN AS OF 01 APR 2025 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 REPORTED EVENT BUT IS RELAYING THE INFORMATION PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE AVANOS MEDICAL 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, 30302423, IN THIS COMPLAINT WAS REVIEWED AND THE MATERIAL WAS PRODUCED ACCORDING TO THE MANUFACTURING PROCEDURES AND MET THE QUALITY REQUIREMENTS. THE SAMPLE WAS RECEIVED WITHOUT THE PRODUCT PACKAGING. THE LOT NUMBER WAS NOT CONFIRMED. THE TWO LOOSE ANCHORS WERE RECEIVED WITH SIGNIFICANT DRIED BLOOD. THERE WERE SOME RUMINANTS AFTER DECONTAMINATION. BOTH HAVE A SEGMENT OF SUTURE EXTENDING FROM THE FLAT SIDE OF THE ANCHOR. ONE MEASURES APPROXIMATELY 1.8CM. THE OTHER MEASURES APPROXIMATELY 2.3CM NO PORTION OF SUTURE EXTENDED FROM THE OTHER SIDE OF THE ANCHORS. ROOT CAUSE COULD NOT BE DETERMINED. ALL INFORMATION REASONABLY KNOWN AS OF 09-OCT-2025 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 REPORTED EVENT BUT IS RELAYING THE INFORMATION PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE AVANOS MEDICAL 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

    PER ADDITIONAL INFORMATION RECEIVED ON 11APR2025, ¿EXPLANATION OF THE PROCEDURE AND ITS RISKS, AND FREE AND INFORMED CONSENT OF THE PATIENT. ADMINISTRATION OF GLUCAGON: 1 MG I.V. INSUFFLATION OF 70 ML OF AIR THROUGH NASOGASTRIC TUBE. ASEPSIS FOLLOWED BY THE USUAL BLACKMAIL. LOCAL ANESTHESIA (XYLOCAINE 1% 20 ML) OF THE APPROACH. PUNCTURE UNDER SCOPY AND PLACEMENT OF GASTROPEXY ANCHOR ANGLES. PUNCTURE IN THE CENTER OF THE ANCHORS UNDER FLUOROSCOPIC CONTROL. PLACEMENT OF AN AMPLATZ GUIDE THAT WRAPS CORRECTLY AROUND THE STOMACH. PATH DILATATION AND PLACEMENT OF 16 F PEELABLE INTRODUCER. COMPLICATION PER PROCEDURE: SIMULTANEOUS WIRE BREAKAGE ON ALL THREE ANCHORS. ATTEMPT TO INSERT GASTROSTOMY TUBE 12 F. BALLOON INFLATED WITH 5 ML OF WATER FOR INJECTION. FINAL CHECK UNDER CT SCAN DOES NOT CONFIRM CORRECT GASTROSTOMY POSITION. THE GASTROSTOMY TUBE COULD NOT BE POSITIONED CORRECTLY DUE TO RAPID SWELLING OF THE STOMACH CAUSED BY RELEASE OF THE 3 GASTROPEXY POINTS. BALLOON INFLATION. GASTROSTOMY TUBE REMOVED.¿ THERE WAS NO INJURY TO THE PATIENT.

    Description of Event or Problem · 0

    AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED MULTIPLE INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS IN ONE PACK, INVOLVING ONE PATIENT. THIS IS THE SECOND OF TWO REPORTS. REFER TO 9611594-2025-00071 FOR THE FIRST REPORT. IT WAS REPORTED, ¿PROBLEM DURING A GASTROSTOMY INSERTION THIS MORNING AT THE POLYCLINIC. THE ANCHORS FAILED DURING INSERTION AND DILATION, DESPITE POST-USE CHECKS.¿ NO INJURY OR MEDICAL INTERVENTIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1041255 INTRODUCER KIT FOR GASTROSTOMY FEEDING TUBE DH EF PERC PLACEMENT PRODUCTS KGC AVANOS MEDICAL INC. 98432 30302423

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male