BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIC-KEY GASTROSTOMY FEED TUBE, ENFIT,12 FR,1CM

    MDR report key: 16463393 · Received March 1, 2023

    Report

    Report Number
    9611594-2023-00034
    Event Type
    Malfunction
    Date Received
    March 1, 2023
    Report Date
    April 20, 2023
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KNT
    UDI-DI
    00350770426983
    PMA / PMN Number
    K043114
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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 (B)(6) 2023 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, 30215121, 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 19-APR-2023 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THE GASTROSTOMY TUBE BROKE OFF INSIDE OF THE CHILD AT DAYCARE. THE TUBE BROKE APART AND WAS TOLD THAT PART OF IT WAS STILL INSIDE BUT WAS REMOVED BY THE CAREGIVER. EMAIL FROM REP VIA CUSTOMER "RECENTLY, I HAD GOTTEN A CALL FROM (B)(6). THEY HAVE HAD 3 OF HIS G-TUBE'S BREAK PER MOM. HE HAD ONE FOR 3 DAYS THAT WAS SHIPPED ON (B)(6) 2023. MOM SAID IT BROKE OFF INSIDE OF THE CHILD AT DAYCARE. I WANTED TO SEE IF WE CAN REACH OUT THE MANUFACTURER ABOUT THIS ISSUE TO HELP WITH SENDING OUT A NEW ONE FOR THEM. SHE DOES NOT HAVE A BACKUP AND THE CHILD CANNOT GO TO DAYCARE WITH OUT ONE. IN ADDITION, I WANTED TO LET BOB KNOW ABOUT THIS SINCE HE IS SEEN AT AL DUPONT HOSPITAL. MOM SAID THEY ARE SEEING THE SURGEON NEXT WEEK TO SEE IF THERE ARE ISSUES WITH THE SIZE OF THE TUBE. I NEED TO CALL MOM BACK TODAY AND WOULD LIKE TO HAVE A PLAN FOR HER. CAN YOU PLEASE ASSIST ME WITH THIS. I CAN SEND ONE OUT BUT WE WANTED TO SEE IF THE MANUFACTURER WILL COVER THIS COST. IF YOU CAN LET ME KNOW BY NOON, IT WOULD BE GREAT SO I CAN CALL HER AND GET THE TUBE SENT OUT TODAY IF POSSIBLE. THE ITEM NUMBER IS AVA-81401210. IT IS A 12 FR WITH 1.0 CM"-ABARRETT EMAIL FROM CUSTOMER IN RESPONSE TO "MOM SAID IT BROKE OFF INSIDE OF THE CHILD AT DAYCARE¿ W/ DETAIL "SHE SAID THE TUBE BROKE APART" AND "I WAS TOLD THAT PART OF IT WAS STILL INSIDE BUT WAS REMOVED BY THE CAREGIVER" AND "HE IS USING HIS BACK UP G TUBE" AND "MOM SAID HE WAS OK". PATIENT IS MALE, DOB (B)(6) 2021. NOT ABLE TO CONFIRM LOT NUMBERS OR IF SAMPLES ARE AVAILABLE.-ABARRETT (B)(6) 2023 EMAIL FROM CUSTOMER LOT NUMBER IS 30215121.-ABARRETT

    Description of Event or Problem · 0

    IT WAS REPORTED THE GASTROSTOMY TUBE BROKE OFF INSIDE OF THE CHILD AT DAYCARE. THE TUBE BROKE APART AND "...WAS TOLD THAT PART OF IT WAS STILL INSIDE BUT WAS REMOVED BY THE CAREGIVER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1181866 MIC-KEY GASTROSTOMY FEED TUBE, ENFIT,12 FR,1CM DH EF BALLOON TUBES PRODUCTS KNT AVANOS MEDICAL INC. 8140-12-1.0 30215121 00350770426983

    Patients

    Seq Age Sex Outcome Treatment
    1 Male