BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHILEY LOW PRESSURE CUFFED TRACHEOSTOMY TUBE

    MDR report key: 220185 · Received April 21, 1999

    Report

    Report Number
    2029387-1998-00119
    Event Type
    Malfunction
    Date Received
    April 21, 1999
    Date of Event
    August 1, 1998
    Report Date
    September 27, 1998
    Manufacturer
    MALLINCKRODT MEDICAL, INC.
    Product Code
    BTO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HOMECARE PATIENT EXPERIENCED DIFFICULTIES WITH THE SEAL AND FIT ON ONE (1), SIZE 8 LPC, LOW PRESSURE CUFFED TRACHEOSTOMY TUBE. THE REPORTER STATES THAT AUDIBLE AIR LEAKS WERE OCCURRING AT THE INNER/OUTER CANNULA CONNECTION. THE 8 LPC DEVICE HAD REPORTEDLY BEEN IN USE ONE (1) DAY WHEN THE PROBLEMS OCCURRED. THERE WAS ONE (1) PATIENT INVOLVED WITH NO REPORTED PATIENT INJURY. THE INVOLVED SIZE 8 LPC DEVICE WAS RETURNED TO THE MANUFACTURER ON 09/24/1998 FOR DECONTAMINATION, ANALYSIS AND INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHILEY LOW PRESSURE CUFFED TRACHEOSTOMY TUBE Implant TRACHESTOMY TUBE BTO MALLINCKRODT MEDICAL, INC. 8 PLC M83624000

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR 1. LP-10 VENTILATOR, 2.VARIOUS CONNECTORS/ADAPTORS| (MFG. MODEL TYPES UNK).