BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHILEY LOW PRESSURE CUFFED TRACHEOSTOMY TUBE

    MDR report key: 211459 · Received February 18, 1999

    Report

    Report Number
    2029387-1998-00087
    Event Type
    Malfunction
    Date Received
    February 18, 1999
    Date of Event
    July 2, 1998
    Report Date
    February 9, 1999
    Manufacturer
    MALLINCKRODT MEDICAL, INC.
    Product Code
    BTO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT INFLATION DIFFICULTIES OCCURRED DURING PRE-INSERTION TESTING OF ONE SIZE 6 LPC, LOW PRESSURE CUFFED TRACHEOSTOMY TUBE. THE REPORTER STATED THAT THE LUER VALVE ON THE DEVICE PILOT BALLOON WAS DEFECTIVE. A SECOND 6 LPC DEVICE WAS USED WITH NO FURTHER PROBLEMS OCCURRED. THERE WAS NO DIRECT PT INVOLVEMENT. THE 6 LPC DEVICE HAS BEEN RETURNED TO THE MFR FOR IDENTIFICATION, ANALYSIS AND INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHILEY LOW PRESSURE CUFFED TRACHEOSTOMY TUBE TRACHEOSTOMY TUBE BTO MALLINCKRODT MEDICAL, INC. 6 LPC M61369000

    Patients

    Seq Age Sex Outcome Treatment
    1 NA SYRINGE, MFR MODEL TYPE UNKNOWN.