BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PAED. TRACHEOSTOMY TUBE 4.5MM UNCUFFED 1/EA

    MDR report key: 21762673 · Received April 3, 2025

    Report

    Report Number
    3012307300-2025-03684
    Event Type
    Malfunction
    Date Received
    April 3, 2025
    Date of Event
    February 28, 2025
    Report Date
    June 3, 2025
    Manufacturer
    SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.
    Product Code
    JOH
    PMA / PMN Number
    K083641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: EVALUATION CODES UPDATED. ONE (1) USED DEVICE WAS RECEIVED FOR EVALUATION. A VISUAL INSPECTION WAS PERFORMED, AND THE REPORTED ISSUE COULD BE DUPLICATED. FLANGE OBSERVED TO BE BROKEN AND SEPARATED FROM THE TRACH. A LEFT FLANGE OF THE TRACH WAS OBSERVED TO BE TORN OFF THE SET. THE PROBABLE CAUSE WAS UNKNOWN. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED WHICH INDICATED ALL INSPECTIONS WERE COMPLETED AND NO ISSUES WERE NOTED DURING MANUFACTURE.

    Additional Manufacturer Narrative · 0

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE IS A CRACK IN THE FLANGE. THE DATE OF EVENT WAS 28-FEB. THE EVENT OCCURRED IN PATIENT'S HOME. THERE WAS NO DISINFECTION OR STERILIZATION, AND NO INFECTIOUS DISEASE OCCURRED. THIS OCCURRED WHILE PATIENT USE, NO PATIENT HARM/ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    731260 PAED. TRACHEOSTOMY TUBE 4.5MM UNCUFFED 1/EA TUBE TRACHEOSTOMY AND TUBE CUFF JOH SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown