BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX ENDOTRACHEAL TUBE

    MDR report key: 13455940 · Received February 4, 2022

    Report

    Report Number
    3012307300-2022-02585
    Event Type
    Malfunction
    Date Received
    February 4, 2022
    Date of Event
    April 1, 2021
    Report Date
    February 4, 2022
    Manufacturer
    SMITHS MEDICAL INTERNATIONAL, LTD.
    Product Code
    BTR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ONE DEVICE WAS RETURNED FOR INVESTIGATION. THE RETURNED SAMPLE WAS VISUALLY INSPECTED AND THE CUSTOMER'S COMPLAINT OF WASTE CARDBOARD WAS CONFIRMED HOWEVER BECAUSE THE PACKAGING HAD BEEN OPENED THE CARDBOARD COULD NOT BE TRACED TO MANUFACTURING. A DHR WAS COMPLETED AND FOUND THAT LOT 3994263 WAS MANUFACTURED WITH (B)(4) UNITS; LOT MET THE REQUIREMENTS TO RELEASE THE LOT WITH NO DEVIATIONS IDENTIFIED DURING THEIR MANUFACTURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING PRE-USE CHECK, THE CUSTOMER FOUND WASTE CARDBOARD PIECES MIXED IN THE PACKAGE WITH THE DEVICE. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1562768 PORTEX ENDOTRACHEAL TUBE TUBE, TRACHEAL (W/WO CONNECTOR) BTR SMITHS MEDICAL INTERNATIONAL, LTD. 3994263

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown