BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX® BLUE LINE ULTRA® TRACHEOSTOMY TUBE

    MDR report key: 7679250 · Received July 11, 2018

    Report

    Report Number
    3012307300-2018-02618
    Event Type
    Malfunction
    Date Received
    July 11, 2018
    Date of Event
    June 5, 2018
    Report Date
    October 10, 2018
    Manufacturer
    SMITHS MEDICAL ASD; INC.
    Product Code
    JOH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING DECONTAMINATED SAMPLES WERE RECEIVED IN PLASTIC BAGS WITHOUT THEIR ORIGINAL PACKAGING: 005/073/690 9MM BLU THIN WALL INNER CANNULA 1/EA; 007/920/290 BLU THIN WALL FENES. INNER CANN. 9.0MM S/ASSY 1/EA; 007/075/490 BLU TRACHY TUBE SUB-ASSEMBLY, UNCUFF, FENESTRATED, 9.0MM. UNDER VISUAL INSPECTION THE TECHNICIAN NOTICED THAT THE INNER CANNULA OF 005/073/690 WAS PROTRUDING 2MM FROM 007/075/490. THE DEVICE WAS MEASURED BY A RULER G:01269-CZ. THE CALIBRATION WAS VALID UNTIL AUGUST 2021. FURTHERMORE THE TECHNICIAN NOTICED THAT THERE WERE CRACKS AND SPLITS ON THE SAME CANNULA. THE SECOND INNER CANNULA 007/920/290 AND TRACHEOSTOMY TUBE WERE FOUND TO BE WITHOUT ANY VISUAL DEFECTS NOR INNER CANNULA PROTRUSIONS. INNER CANNULAS ARE PURCHASED COMPONENTS. IT WAS FOUND THAT IN (B)(6) 2018 (B)(6) MEDICAL RAISED COMPLAINT AGAINST SUPPLIER AVENUE (SCAR 00213) DUE TO THE SAME PROBLEM WHICH WERE IDENTIFIED BY CUSTOMERS. THE SUPPLIER INVESTIGATION OUTCOME WAS THAT THE PROBLEMS REPORTED BY THE CUSTOMERS DID NOT OCCUR IN AVENUE AND IT IS MORE RELATED TO LONG TERM USE. THE CUSTOMER WAS ASKED FOR ADDITIONAL INFORMATION ABOUT THE CLEANING METHOD. A RESPONSE WAS RECEIVED THAT THE INNER CANNULA BECAME LONGER AFTER 14 DAYS IN USE AND THAT CLEANING WAS DONE ACCORDING TO IFU. BASED ON THE LOW OCCURRENCE OF THIS ISSUE, AND ALL THE AVAILABLE INFORMATION WE ARE NOT ABLE TO DETERMINE THE ROOT CAUSE OF THIS PROBLEM.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED INDICATING THAT AN INNER CANNULA TO A SMITHS MEDICAL PORTEX® BLUE LINE ULTRA® TRACHEOSTOMY TUBE BECAME INCREASINGLY LONGER IN LENGTH. REPORTED CANNULA CLEANING 2-3 TIMES A DAY WITH 30 DEGREES OF WATER IS NOTED TO BE NOW LONGER THAN THE OUTER CANNULA. NOTED STOMAL BLEEDING AND INFLAMMATION FOLLOWING A DOCTOR'S APPOINTMENT. THERE WERE NO REPORTED ADVERSE EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    519867 PORTEX® BLUE LINE ULTRA® TRACHEOSTOMY TUBE TUBE TRACHEOSTOMY AND TUBE CUFF JOH SMITHS MEDICAL ASD; INC. 3444002

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR