BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX

    MDR report key: 13193837 · Received January 7, 2022

    Report

    Report Number
    3012307300-2022-00302
    Event Type
    Malfunction
    Date Received
    January 7, 2022
    Date of Event
    December 1, 2021
    Report Date
    June 9, 2022
    Manufacturer
    SMITHS MEDICAL INTERNATIONAL, LTD.
    Product Code
    BTR
    UDI-DI
    15019315020353
    PMA / PMN Number
    K931735
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    H10: DEVICE EVALUATION: THE DEVICE WAS RETURNED FOR INVESTIGATION. A VISUAL INSPECTION AND FUNCTIONAL TEST WERE PERFORMED. PHOTOS RECEIVED: FIVE (5) PHOTOS WERE INCLUDED IN AGILE ATTACHMENTS FOR EVALUATION. RESULTS: NO DEFECTS WERE FOUND. SAMPLES RETURNED: ONE (1) SAMPLE WAS RETURNED FOR EVALUATION P/N 100/133/070; THE SAMPLE WAS RECEIVED IN USED CONDITIONS WITHOUT ORIGINAL PACKAGE. VISUAL INSPECTION: THE RETURNED SAMPLE WAS VISUALLY INSPECTED AT 12? TO 16? AND NORMAL CONDITIONS OF ILLUMINATION. RESULTS: NO DEFECTS WERE FOUND. FUNCTIONAL TESTING: THE PILOT BALLOON OF THE SAMPLES RETURNED WAS INFLATED USING A SYRINGE TO DETECT ANY DEFECTS. RESULTS: LEAKAGE ON CUFF WAS DETECTED; THE COMPLAINT WAS CONFIRMED. LEAK TESTING: THE SAMPLES RETURNED WERE CONNECTED TO LEAK TESTER MACHINE [CAL ID: 8.1597, DUE DATE: MARCH,2022] TO IDENTIFY ANY LEAK. RESULTS: LEAKAGE WAS DETECTED THE SAMPLE RETURNED. BASED ON THE ANALYSIS CONDUCTED IN THE SAMPLE PROVIDED, THE ROOT CAUSE IS THE UNIT BECAME DAMAGED AFTER IT LEFT SMITHS MEDICAL FACILITIES SINCE UNITS SHOULD BE PRE-CHECKED BEFORE USE IN PATIENTS. THE CAUSE OF THE REPORTED PROBLEM COULD NOT BE DETERMINED. ANY RELEVANT DMRS, NCRS, ETS, ETC.: THERE WERE NO ISSUES, NONCONFORMANCE REPORTED DURING THE MANUFACTURE OF THIS LOT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE PRE-USE CHECK, LEAKAGE OF AIR FROM THE CUFF WAS OBSERVED. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    993122 PORTEX TUBE, TRACHEAL (W/WO CONNECTOR) BTR SMITHS MEDICAL INTERNATIONAL, LTD. 100/133/070 4080566 15019315020353

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown