BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHILEY CUFFLESS TRACHEOSTOMY TUBE

    MDR report key: 46175 · Received October 24, 1996

    Report

    Report Number
    2029387-1996-00139
    Event Type
    Malfunction
    Date Received
    October 24, 1996
    Report Date
    October 22, 1996
    Manufacturer
    MALLINCKRODT MEDICAL, INC.
    Product Code
    BTO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE: THIS IS A FOLLOW-UP REPORT TO PROVIDE EVALUATION RESULTS (SECTION H6). THE DEVICES WERE RETURNED ON 10/14/96. LOT NUMBERS, EXPIRATION DATES, AND MFG DATES, FOR SECTIONS D6, D5, AND H4, RESPECTIVELY, ARE PROVIDED AS FOLLOWS: LOT# 9399011600, 9499146500, M60536000, 9399164800, 9499237500, 9499146400, M51194000. QTY 1, 1, 1, 1, 2, 1, 1. EXP DATE 02/1998, 05/1999, 02/2001, 08/1998, 07/1999, 05/1999, 03/1995. MFG DATE 02/1993, 05/1994, 02/1996, 08/1993, 07/1994, 05/1994, 03/2000. IT SHOULD BE NOTED THAT THE PATIENT HAD COLLECTED THE DEVICES AT HOME BEFORE INFORMING HIS HOME CARE THERAPIST OF THIS DEVICE PROBLEM. THE EVALUATION VERIFIED THE CRACKED TRACH HEADS. A NEW THICKER TRACH HEAD DESIGN HAS SINCE BEEN IMPLEMENTED. REPLACEMENT DEVICES WITH THE NEW DESIGN WERE SENT.

    Description of Event or Problem · 1

    THE PATIENT HAD COLLECTED 6 TO 8 SIZE 6 CFS TRACHEOSTOMY TUBES THAT HAD CRACKED AT THE THREE O'CLOCK POSITION OF THE TRACH HEAD. NO PATIENT INJURY WAS REPORTED. THE CRACKS OCCURRED AFTER LESS THAN 2 MONTHS OF USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHILEY CUFFLESS TRACHEOSTOMY TUBE TRACHEOSTOMY TUBE BTO MALLINCKRODT MEDICAL, INC. 6CFS SEE SECTION H10

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN