BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX

    MDR report key: 10949567 · Received December 4, 2020

    Report

    Report Number
    3012307300-2020-12115
    Event Type
    Malfunction
    Date Received
    December 4, 2020
    Date of Event
    November 1, 2020
    Report Date
    January 18, 2021
    Manufacturer
    SMITHS MEDICAL INTERNATIONAL, LTD.
    Product Code
    JOH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    OTHER, OTHER TEXT: INVESTIGATION COMPLETED ON A SMITHS MEDICAL TRACHEOSTOMY/PVC - PORTEX TUBES BLUE LINE ULTRA (BLU) PICTURES RECEIVED AND VISUALLY INSPECTED PER PROTOCOL AND NO DISCREPANCIES WAS DETECTED. FUNCTIONAL TESTING WITH SAMPLE RECEIVED FROM PN: 100/860/780 AND TESTED. THE RESULT REVEALED WITH INFLATING AIR WITH SYRINGE INTO CUFF AND SUBMERGING UNDER WATER NO LEAKAGE WAS DETECTED. NO AIR BUBBLES CAME OF CUFF. PICTURE ATTACHED. ENGINEERING REVIEWED AND TESTING PRIOR TO RELEASE OF PRODUCT PASSED AT 100%. NO FAULT COULD BE ESTABLISHED WITH PRODUCT.

    Description of Event or Problem · 0

    INVESTIGATION COMPLETED AND SUMMARIZED IN H 10.

    Additional Manufacturer Narrative · 1

    ONLY THE MONTH ((B)(6)) AND YEAR (2020) OF THE AWARE DATE ARE KNOWN. (B)(6). DEVICE EVALUATION IN PROGRESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUFF ON THE PORTEX BLUE LINE ULTRA (BLU) TRACHEOSTOMY TUBE WAS LEAKING. THIS PRODUCT PROBLEM WAS OBSERVED DURING PATIENT USE. NO PATIENT INJURY OR COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1409405 PORTEX TUBE TRACHEOSTOMY AND TUBE CUFF JOH SMITHS MEDICAL INTERNATIONAL, LTD. 100/860/070

    Patients

    Seq Age Sex Outcome Treatment
    1