BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHILEY TRACHEOSTOMY TUBE, SIZE 8

    MDR report key: 12153 · Received March 21, 1994

    Report

    Report Number
    MW1001174
    Event Type
    Injury
    Date Received
    March 21, 1994
    Date of Event
    January 11, 1994
    Manufacturer
    MALLINCKRODT MEDICAL TPI, INC.
    Product Code
    BTO
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DR ASKED FOR A NUMBER 8 TRACHEOSTOMY TUBE. AN 8 TRACH TUBE BOX WAS TAKEN FROM SUPPLY BOX. TUBE OPENED ON THE STERILE FIELD. TRACH TUBE WAS INSERTED AND PT RETURNED TO THE UNIT. THE UNIT CALLED AS PT WAS HAVING TROUBLE BEING VENTILATED. IT WAS DISCOVERED THAT THE TUBE WAS A SIZE 6 INSTEAD OF A SIZE 8. PT WAS BROUGHT BACK TO SURGERY. THE NUMBER 6 TUBE WAS EXCHANGED FOR THE NUMBER 8 TUBE. APPARENTLY THE WRONG TUBE WAS IN THE ORIGINAL BOX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHILEY TRACHEOSTOMY TUBE, SIZE 8 TRACHEOSTOMY TUBE BTO MALLINCKRODT MEDICAL TPI, INC. 9399158600

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Hospitalization