BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHILEY FENESTRATED LOW PRESSURE CUFFED TRACHEOSTOMY TUBE

    MDR report key: 163000 · Received April 3, 1998

    Report

    Report Number
    2029387-1997-00220
    Event Type
    Injury
    Date Received
    April 3, 1998
    Date of Event
    December 9, 1997
    Report Date
    March 26, 1998
    Product Code
    BTO
    Adverse Event
    Yes
    Report Source
    Manufacturer report

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED VIA RECEIPT OF UF MEDWATCH REPORT THAT A PT WITH A SIZE 10 FEN, FENESTRATED LOW PRESSURE CUFFED TRACHEOSTOMY TUBE EXPERIENCED RESPIRATORY DISTRESS AND REQUIRED INTERVENTION DUE TO A REPORTED LEAKAGE BETWEEN THE INNER AND OUTER CANNULA. THIS WAS DETECTED SHORTLY AFTER INITIAL PLACEMENT. IT IS UNK IF THE DEVICE WAS TESTED PRIOR TO INSERTION. THE 10 FEN DEVICE WAS REMOVED AND REPLACED WITH A SIZE 9 SCT, SINGLE CANNULA CUFFED TRACHEOSTOMY TUBE WITH NO FURTHER PROBLEMS ENCOUNTERED. THERE WAS ONE PT INVOLVED WHO HAS RETURNED TO BASELINE CONDITION. THE 10FEN DEVICE WAS RETURNED TO THE MFR FOR DECONTAMINATION, ANALYSIS AND INVESTIGATION ON 12/23/97.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHILEY FENESTRATED LOW PRESSURE CUFFED TRACHEOSTOMY TUBE TRACHEOSTOMY TUBE BTO 10 FEN M52326000

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention