BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHILEY

    MDR report key: 21352073 · Received February 10, 2025

    Report

    Report Number
    8020889-2025-00104
    Event Type
    Injury
    Date Received
    February 10, 2025
    Date of Event
    January 13, 2025
    Report Date
    February 17, 2025
    Manufacturer
    MALLINCKRODT MEDICAL
    Product Code
    JOH
    UDI-DI
    10884521205444
    PMA / PMN Number
    K150844
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: G3, H6 THIS EVENT HAS BEEN FOUND TO BE A DUPLICATE OF A PREVIOUSLY REPORTED EVENT DOCUMENTED UNDER RR# 8020889-2025-00104. ALL ADDITIONAL I NFORMATION PERTAINING TO THIS EVENT WILL BE COMMUNICATED UNDER THE ORIGINAL REGULATORY REPORT NUMBER OF 8020889-2025-00080. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE TRACHEOSTOMY TUBE CANNULA WAS FOUND BROKE IN THE PATIENT'S TRACHEA WHEN THE PATIENT ASKED FOR AN ASPIRATION. THE PATIENT WAS TREATED PROMPTLY FOR REMOVAL OF THE DEVICE THAT WAS OBSTRUCTING HIS TRACHEA. PATIENT TRANSFERRED TO THE ENT OPERATING ROOM FOR THE EXTRACTION OF THE OUTER JACKET THAT WAS OBSTRUCTING THE TRACHEA. CANNULA CHANGE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1657907 SHILEY TUBE TRACHEOSTOMY AND TUBE CUFF JOH MALLINCKRODT MEDICAL 7CN80R 20245258X 10884521205444

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening| R