BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX BLUE LINE ULTRA TRACHEOSTOMY TUBE

    MDR report key: 9549552 · Received January 3, 2020

    Report

    Report Number
    3012307300-2020-00024
    Event Type
    Malfunction
    Date Received
    January 3, 2020
    Date of Event
    December 1, 2019
    Report Date
    March 12, 2020
    Manufacturer
    SMITHS MEDICAL ASD; INC.
    Product Code
    JOH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: RETURNED DEVICE WAS RECEIVED IN GOOD PHYSICAL CONDITION. DURING THE EVALUATION OF THE DEVICE A BUBBLE COMING OUT OF THE SMALL TEAR IN THE CUFF OF THE RETURNED SAMPLES BY CUSTOMER. THE CUSTOMER REPORTED CONDITION WAS CONFIRMED. PROBLEM SOURCE WAS TRACED TO USER INTERFACE. THE DEVICE HISTORY RECORD WAS REVIEWED AND SHOWED THAT THIS DEVICE MET ALL MANUFACTURING SPECIFICATION FOR PRODUCT RELEASED FOR DISTRIBUTION. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT.

    Additional Manufacturer Narrative · 1

    TWO COMPLAINTS FILED TO REFLECT REPORTED AIR LEAKAGE FROM TWO TUBES. 3012307300-2020-00026-0061455, 3012307300-2020-00024-0061243.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED INDICATING THAT ONE DAY FOLLOWING PLACEMENT OF A SMITHS MEDICAL PORTEX® BLUE LINE ULTRA® TRACHEOSTOMY TUBE, AIR WAS OBSERVED LEAKING FROM THE TUBE. THE TUBE WAS THEN REPLACED BUT AIR LEAKAGE OCCURRED AGAIN. SUBSEQUENTLY, A THIRD TRACH TUBE WAS PLACED WITH NO REPORTED ADVERSE PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11697 PORTEX BLUE LINE ULTRA TRACHEOSTOMY TUBE TUBE TRACHEOSTOMY AND TUBE CUFF JOH SMITHS MEDICAL ASD; INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention