BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHILEY

    MDR report key: 24532158 · Received March 6, 2026

    Report

    Report Number
    24532158
    Event Type
    Malfunction
    Date Received
    March 6, 2026
    Date of Event
    January 2, 2026
    Report Date
    January 6, 2026
    Manufacturer
    COVIDIEN LP
    Product Code
    JOH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    TRACH TUBE CUFF INFLATION MALFUNCTION. SECOND TRACH TUBE WHERE THE CUFF WOULD NOT STAY INFLATED. LOT:25F0740JZX EXP: 06/23/2030 MANUFACTURER: COVIDIEN SIZE:8.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    589511 SHILEY TUBE TRACHEOSTOMY AND TUBE CUFF JOH COVIDIEN LP 7CN80A 25F0740JZX

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Unknown Other