BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIC-KEY GASTROSTOMY FEEDING TUBE, EXTENSION SETS WITH ENFIT CONNECTORS - 14 F

    MDR report key: 12467741 · Received September 14, 2021

    Report

    Report Number
    9611594-2021-00120
    Event Type
    Malfunction
    Date Received
    September 14, 2021
    Date of Event
    July 2, 2021
    Report Date
    September 14, 2021
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KNT
    UDI-DI
    00350770427355
    PMA / PMN Number
    K043114
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD FOR THE REPORTED LOT NUMBER, 30095962, IN THIS COMPLAINT WAS REVIEWED AND THE MATERIAL WAS PRODUCED ACCORDING TO THE MANUFACTURING PROCEDURES AND MET THE QUALITY REQUIREMENTS. THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. 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 · 1

    IT WAS REPORTED VIA FDA MEDWATCH / FDA USER FACILITY REPORT # MW (B)(4) THE FOLLOWING: PATIENT WITH NEW MICKEY GASTR[OST]OMY TUBE (GT) INSERTED TODAY. UPON ARRIVAL AND THROUGHOUT SHIFT-MICKEY BUTTON WAS IN PLACE, WITH THREE SUTURE/BUTTONS IN PLACE. GAUZE WAS PLACED OVER THE SITE-DUE TO PATIENT HAVING ANXIETY WHEN LOOKING AT NEW GT. GAUZE WITH SCANT SEROSANGUINOUS DRAINAGE NOTED. GT VENTING. IN EVENING- DAY AND NIGHT RN HANDOFF, LIFTED GOWN TO FIND SITE WAS BLEEDING, ONE OF THE THREE BUTTONS WAS COMPLETELY DETACHED, MICKEY BUTTON WAS COMPLETELY OUT. MICKEY BALLOON WAS FOUND TO BE DEFLATED. MD NOTIFIED . EXTRA STAFF WERE CALLED TO BEDSIDE. UPON CHECKING THE BALLOON, THE BALLOON WAS STILL COMPLETELY INTACT. UNSURE OF WHERE THE FLUID IN THE BALLOON COULD HAVE GONE AS IT WAS NOTED IN THE SURGICAL NOTE THAT IS WAS INFLATED WITH 5ML STERILE WATER. 14 FRENCH 1.5CM GT KIT AT BEDSIDE, ALONG WITH A 12 FRENCH ROB-NEL CATHETER. IN ACCORDANCE TO ADVICE FROM THE GI FELLOW, THE SENIOR RESIDENT, REINSERTED A NEW MICKEY BUTTON. PATIENT WAS MEDICATED PRIOR TO PROCEDURE WITH DILAUDID PRO RE NATA (PRN) DOSE. THERE WAS NO HARM IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1368549 MIC-KEY GASTROSTOMY FEEDING TUBE, EXTENSION SETS WITH ENFIT CONNECTORS - 14 F DH EF BALLOON TUBES PRODUCTS KNT AVANOS MEDICAL INC. 8140-14-3.0 30095962 00350770427355

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Other