BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX BLUE LINE ULTRA TRACHEOSTOMY TUBE

    MDR report key: 16837872 · Received April 28, 2023

    Report

    Report Number
    3012307300-2023-04766
    Event Type
    Malfunction
    Date Received
    April 28, 2023
    Date of Event
    March 14, 2023
    Report Date
    August 7, 2023
    Manufacturer
    SMITHS MEDICAL INTERNATIONAL, LTD.
    Product Code
    BTO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: THE INVESTIGATION OF THIS COMPLAINT WAS LIMITED BECAUSE NO SAMPLE WAS RETURNED, THEREFOR FUNCTIONAL TESTING COULD NOT BE COMPLETED. THE CUSTOMER PROVIDED TWO PHOTOS. BASED ON PROVIDED PHOTOS PRODUCT MIX-UP IS CONFIRMED. THE CHINESE LABELS WHICH ARE SHOWN ON PROVIDED PHOTOS ARE NOT PLACED ON PRODUCTS BY THE MANUFACTURING COMPANY. THE CHINESE LABELS ARE PLACED ON PRODUCT BY THE CUSTOMER. DURING THIS ACTIVITY UNIT PACKS HAD TO BE REMOVED FROM SHELF CARTONS. WE BELIEVE THAT PRODUCT MIX-UP HAPPENED DURING THIS ACTIVITY WHICH IS OUT OF CONTROL OF THE MANUFACTURER. A REVIEW OF THE DEVICE HISTORY RECORDS (DHR) FOR BOTH ITEM NUMBERS, SHOWED THERE WERE NO OBSERVATIONS OR NONCONFORMITIES RECORDED DURING MANUFACTURE TO SUGGEST AN ISSUE OF THIS NATURE WOULD OCCUR WITH THIS LOT OF PRODUCTS. BASED ON AN EMAIL RESPONSE, THE ISSUE WAS CAUSED BY HOSPITAL WAREHOUSE ADMINISTRATOR. HOSPITAL WAS INSTRUCTED TO CORRECT LABELLING.

    Additional Manufacturer Narrative · 0

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN REQUIRED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEPARTMENT OPENED AND FOUND THAT THE SPECIFICATIONS DISPLAYED (SHOWN SPECIFICATIONS: 100/800/080) IN THE OUTER PACKAGING DID NOT MATCH THE ACTUAL DEVICE SPECIFICATIONS (DEVICE RECEIVED SPECIFICATIONS: 100/860/080). NO PATIENT INVOLVEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1362767 PORTEX BLUE LINE ULTRA TRACHEOSTOMY TUBE TUBE, TRACHEOSTOMY (W/WO CONNECTOR) BTO SMITHS MEDICAL INTERNATIONAL, LTD. 100/800/080 4129419

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown