BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX

    MDR report key: 11308478 · Received February 10, 2021

    Report

    Report Number
    3012307300-2021-01119
    Event Type
    Malfunction
    Date Received
    February 10, 2021
    Report Date
    March 26, 2021
    Manufacturer
    SMITHS MEDICAL INTERNATIONAL, LTD.
    Product Code
    BTR
    UDI-DI
    15019315021015
    PMA / PMN Number
    K931735
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    OTHER, OTHER TEXT: RETURNED DEVICE WAS RECEIVED FOR EVALUATION. DURING THE EVALUATION OF THE DEVICE THE CUSTOMER REPORTED CONDITION WAS NOT CONFIRMED. NO FAULT FOUND. 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.

    Description of Event or Problem · 0

    NO MARKING FOR THE VOCAL CORDS WITH TUBES SIZE 5, 5.5, 6 THREE ITEM NUMBERS ARE CONCERNED - 100/134/050, 100/134/055; 100/134/060. 10 UNUSED SAMPLES ARE AVAILABLE PER ITEM NUMBER. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Additional Manufacturer Narrative · 1

    CUSTOMER CONTACT PHONE NUMBER: (B)(6). DEVICE EVALUATION IN PROGRESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PORTEX ENDOTRACHEAL TUBES DID NOT HAVE MARKINGS ON THE VOCAL CORDS WITH SIZES 5, 5.5, AND 5.6. THE PRODUCT PROBLEM WAS OBSERVED UPON OPENING OF THE PACKAGE. NO PATIENT INJURY OR COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203410 PORTEX TUBE, TRACHEAL (W/WO CONNECTOR) BTR SMITHS MEDICAL INTERNATIONAL, LTD. 100/134/060 3858251 15019315021015

    Patients

    Seq Age Sex Outcome Treatment
    1