BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX

    MDR report key: 10469704 · Received August 29, 2020

    Report

    Report Number
    3012307300-2020-08561
    Event Type
    Malfunction
    Date Received
    August 29, 2020
    Date of Event
    June 1, 2020
    Report Date
    October 3, 2020
    Manufacturer
    SMITHS MEDICAL INTERNATIONAL, LTD.
    Product Code
    BTO
    UDI-DI
    15019315038808
    PMA / PMN Number
    K030570
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION COMPLETED ON A SMITHS MEDICAL TRACHEOSTOMY/PVC - PORTEX TUBES BLUE LINE ULTRA (BLU).A SAMPLE WAS RETURNED WITH P/N 100/870/080 THE SAMPLE WAS VISUALLY INSPECTED AT A CLOSE DISTANCE OF 12-16 WITH ONE SMALL TEAR NOTED.WHEN CUFF TESTED UNDER SUBMERGING IN WATER, THE EVENT WAS VERIFIED, AS BUBBLES WITH COMING OUT. RELEVANT DOCUMENTS WITH REVIEWED UPON QUALITY TESTING AND NO MANUFACTURE DISCREPANCIES WERE REVEALED PRIOR TO RELEASE. THE CAUSE IN THEORY IF COULD BE RELATED TO NOT FOLLOWING MANUFACTURE GUIDELINES IN SECTION 4 OF THE IFU 10016503-002 PRIOR TO USE. THE CAUSE IS BELIEVED THE OCCURRENCE OF LEAK WAS AFTER THE PRODUCT LEFT THE MANUFACTURING SITE AND CARE OF PRODUCT BY CONSUMER.

    Description of Event or Problem · 0

    INVESTIGATION COMPLETED ON A SMITHS MEDICAL TRACHEOSTOMY/PVC - PORTEX TUBES BLUE LINE ULTRA (BLU).

    Additional Manufacturer Narrative · 1

    THE DAY OF THE EVENT DATE IS UNKNOWN. ONLY THE MONTH (B)(6) AND YEAR (2020) ARE KNOWN. (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUFF COMPONENT OF THE BLUE LINE ULTRA (BLU) TRACHEOSTOMY TUBE WAS DEFLATING TOO EASILY. NO PATIENT INJURY OR COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    933847 PORTEX TRACHEOSTOMY BTO SMITHS MEDICAL INTERNATIONAL, LTD. 100/870/080 3913697 15019315038808

    Patients

    Seq Age Sex Outcome Treatment
    1