BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX BLUE LINE ULTRA SUCTIONAID

    MDR report key: 14244486 · Received April 28, 2022

    Report

    Report Number
    3012307300-2022-07114
    Event Type
    Malfunction
    Date Received
    April 28, 2022
    Date of Event
    March 1, 2022
    Report Date
    June 2, 2022
    Manufacturer
    SMITHS MEDICAL INTERNATIONAL, LTD.
    Product Code
    BTO
    UDI-DI
    15019517076158
    PMA / PMN Number
    K173384
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    H10: DEVICE EVALUATION: ONE USED DECONTAMINATED SAMPLE 10009163-004 8MM DEHT BLU SUCTIONAID SUB-ASSY WAS RETURNED FOR INVESTIGATION (SEE PHOTO OF SAMPLE). UNDER VISUAL INSPECTION WE NOTICED THAT INFLATION LINE WAS DETACHED FROM PILOT BALLOON. 10001429-004 INFL. LINE S/ASSY SOFT-SEAL 8MM IS ASSEMBLED IN SMITHS MEDICAL TIJUANA THEREFORE SECONDARY INVESTIGATION OBJECT WAS CREATED WITH PURPOSE TO CAPTURE COMPONENT INVESTIGATION. SIMILAR CUSTOMER COMPLAINTS HAVE BEEN RECENTLY RECEIVED THEREFORE INTERNAL NON-CONFORMITY REPORT NCR-000928 WAS CREATED WITH PURPOSE TO EVALUATE THIS ISSUE. SMITHS MEDICAL TIJUANA SITE CONFIRMED THAT NO MORE PHYSICAL COMPLAINT SAMPLES ARE NEEDED FOR INVESTIGATION THEREFORE SAMPLE IS KEPT IN SMITHS MEDICAL CZECH REPUBLIC. A DHR REVIEW WAS PERFORMED SUBSEQUENT TO THE MANUFACTURING OF THE DEVICE AND PRIOR TO ITS RELEASE. NO PROBLEMS OR ISSUES WERE IDENTIFIED DURING THIS DHR REVIEW.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE USE OF THE PRODUCT, THE PILOT BALLOON GOT DETACHED FROM THE INFLATION LINE. NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142226 PORTEX BLUE LINE ULTRA SUCTIONAID TUBE, TRACHEOSTOMY (W/WO CONNECTOR) BTO SMITHS MEDICAL INTERNATIONAL, LTD. 101/860/080CZ 4072314 15019517076158

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown