BEUDAMED
    FDA Adverse Event Death Summary report: N

    SHILEY ADULT FLEXIBLE TRACHEOSTOMY TUBES WITH TAPERGUARD CUFF AND CUFFLESS WITH

    MDR report key: 17309688 · Received July 11, 2023

    Report

    Report Number
    MW5119305
    Event Type
    Death
    Date Received
    July 11, 2023
    Date of Event
    May 26, 2023
    Report Date
    July 9, 2023
    Manufacturer
    COVIDIEN LP
    Product Code
    JOH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    SPOUSE HAD TRACHEOSTOMY AND WAS USING PRODUCTS, SPECIFICALLY CANNULAS, MANGE BY COMPANY MEDTRONIC'S. MEDTRONIC'S SENT OUT INFO THAT THERE WAS A MANUFACTURER ERROR IN THE PRODUCTION "SHILEY ADULT FLEXIBLE TRACHEOSTOMY TUBES WITH TAPERGUARD CUFF AND CUFFLESS WITH DISPOSABLE OR REUSABLE INNER CANNULAS. INFO STATED MY SPOUSE MAY HAVE PURCHASED ITEMS WITH AFFECTED LOT NUMBERS. THEY NOTED THE REASON FOR THE RECALL WAS THAT CONNECTOR COMPONENT OF THE TRACH TUBING CREATED UNSECURED CONNECTION BETWEEN THE DEVICE CONNECTOR AND CIRCUIT COMPONENTS CAPS OR ACCESSORIES. THEY STATED THE RISK TO HEALTH, DYSPNEA TISSUE INJURY AND BLEEDING AND POTENTIAL RESPIRATORY FAILURE. ON (B)(6) 2023 MY SPOUSE WAS AT HOME ON VENTILATORS WHEN SHE WAS UNABLE TO BREATH. CHECK OF VENTILATORS SHOWED IT WAS OPERATING OKAY. SHE WAS UNABLE TO GET AIR IN PAST HER TRACH. 911 CALLED AND ARRIVED APPROXIMATELY 3 MINUTES LATER. THEY APPLIED MEDICATION, HEART PUMP AND BAGGING WITH NEGATIVE RESULTS. TRANSPORTED TO HOSPITAL. SPOUSE USED PRODUCTS FROM MEDTRONIC. AFTER REVIEWING MEDICAL EXAMINER'S REPORT DEATH DUE TO MUCOUS IN HER TRACH WHICH PREVENT AIR FROM GETTING INTO HER SYS. WHICH RESULT IN CARDIAC ARREST. AFTER MEDTRONIC'S NOTICE AND MEDICAL EXAMINER'S REPORT I FOUND SEVERAL ITEMS IN MY SPOUSE'S PROPERTY THAT MATCH ITEMS ON THE RECALL LIST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332852 SHILEY ADULT FLEXIBLE TRACHEOSTOMY TUBES WITH TAPERGUARD CUFF AND CUFFLESS WITH TUBE TRACHEOSTOMY AND TUBE CUFF JOH COVIDIEN LP 4CN65H 22DO799JZS

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female Death DISPOSABLE/REUSABLE INNER CANNULAS.