BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX

    MDR report key: 10590972 · Received September 26, 2020

    Report

    Report Number
    3012307300-2020-09861
    Event Type
    Malfunction
    Date Received
    September 26, 2020
    Report Date
    December 28, 2020
    Manufacturer
    SMITHS MEDICAL INTERNATIONAL, LTD.
    Product Code
    BTR
    UDI-DI
    15019315022340
    PMA / PMN Number
    K790312
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    OTHER, OTHER TEXT: FIFTY-FIVE PORTEX ENDOTRACHEAL TUBES WERE RETURNED FOR ANALYSIS. THE SAMPLE WAS RECEIVED IN USED CONDITIONS. THE RETURNED SAMPLE WAS VISUALLY INSPECTED AT A DISTANCE OF 12? TO 16? AND NORMAL CONDITIONS OF ILLUMINATION. NO DISCREPANCIES WERE FOUND. THE CUFF OF THE RETURNED SAMPLE WAS INFLATED USING A SYRINGE AND THE PRODUCT WAS SUBMERGED UNDER WATER IN ORDER TO DETECT ANY LEAK. NO INFLATION ISSUES WERE FOUND IN THE 55 SAMPLES. PRODUCTION PERFORMS A 100% INFLATION TEST TO THE INFLATION LINE AND THE CUFF. QUALITY TAKES A SAMPLE USING AN AQL 1.0 AND A LEVEL INSPECTION G-I IN ORDER TO VERIFY THE VISUAL INSPECTION AND AUDIT LEAK TEST. BASED ON THE ANALYSIS CONDUCTED IN THE SAMPLE PROVIDED, THE COMPLAINT WAS NOT CONFIRMED. NO CORRECTIVE ACTIONS WERE TAKEN SINCE THE COMPLAINT WAS NOT CONFIRMED. DEVICE HISTORY RECORD PART NUMBER = 100 199 080 LOT NUMBER = 3874480 QUANTITY = 51480 UNITS MANUFACTURING DATE = OCTOBER 2019.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED INDICATING THAT WHEN THE PORTEX ENDOTRACHEAL TUBE WAS INSERTED INTO THE PATIENT AND INFLATED AS PER NORMAL PROCEDURE, WHILE THE OPERATION WAS IN PROCESS THE CUFF DEFLATED. THERE WERE NO ADVERSE EVENTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1055498 PORTEX TRACHEOSTOMY TUBE BTR SMITHS MEDICAL INTERNATIONAL, LTD. 100/199/080 3874480 15019315022340

    Patients

    Seq Age Sex Outcome Treatment
    1