BEUDAMED
    FDA Adverse Event Other Summary report: N

    SHILEY INTUBATING STYLET

    MDR report key: 18502320 · Received January 12, 2024

    Report

    Report Number
    18502320
    Event Type
    Other
    Date Received
    January 12, 2024
    Date of Event
    December 16, 2023
    Report Date
    December 22, 2023
    Manufacturer
    COVIDIEN LP
    Product Code
    BSR
    Report Source
    User Facility report
    Reporter Location
    FL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    INITIAL EVENT SEVERITY RATING: EVENT REACHED PATIENT- CAUSED SIGNIFICANT HARM OR REQUIRED MAJOR INTERVENTION. EVENT DESCRIPTION: ON REVIEW OF PRIOR X-RAYS, I NOTED THAT PRIOR RADIOLOGY REPORTS ON MULTIPLE X-RAYS SINCE BIRTH DISCUSS A POSSIBLE FOREIGN BODY IN THE MEDIASTINUM MOST RECENTLY DISCUSSED IN RADIOLOGY READ BY DR.: "AGAIN, AN UNUSUAL VAGUELY RADIO DENSE CATHETER IS SEEN PROJECTING OVER THE MID-MEDIASTINUM AND AT RIGHT HILUM. THE PERSISTENCE OVER TIME AND STABILITY POSITION RAISES CONCERN, THIS RESIDES IN THE PATIENT RATHER THAN ON THE PATIENT. CONSIDER LATERAL CHEST RADIOGRAPHY IN FURTHER ASSESSMENT." I OBTAINED A LATERAL CHEST RADIOGRAPH THAT CONFIRMED THE PRESENCE OF A TUBULAR, RADIOLUCENT STRUCTURE IN THE MID-MEDIASTINUM THAT IS NOT AN INTENTIONALLY PLACED MEDICAL DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1707078 SHILEY INTUBATING STYLET STYLET, TRACHEAL TUBE BSR COVIDIEN LP 85863 23G1162JZX

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown