BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX BLUE LINE ULTRA SUCTIONAID CUFFED TRACHEOSTOMY TUBE

    MDR report key: 21048853 · Received December 31, 2024

    Report

    Report Number
    3011237704-2024-00282
    Event Type
    Malfunction
    Date Received
    December 31, 2024
    Date of Event
    August 26, 2024
    Report Date
    December 31, 2024
    Manufacturer
    SMITHS MEDICAL CZECH REPUBLIC A. S
    Product Code
    BTO
    UDI-DI
    15019517076158
    PMA / PMN Number
    K173384
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D4. PRIMARY UDI NUMBER: THE PRIMARY DI# HAS BEEN USED AS THE LOT/SERIAL INFORMATION IS UNKNOWN. INVESTIGATION SUMMARY: ONE USED DECONTAMINATED 10009163-004 8MM DEHT BLU SUCTIONAID SUB-ASSY WAS RETURNED FOR INVESTIGATION. CUSTOMER IS CLAIMING DETACHMENT OF PILOT BALLOON FROM INFLATION LINE. UNDER VISUAL INSPECTION WE NOTICED THAT INFLATION LINE WAS DETACHED FROM PILOT BALLOON AS REPORTED BY CUSTOMER. THIS ISSUE WAS ESCALATED TO CAPA-000905. NO COMPLAINT SIGNAL IS CURRENTLY OBSERVED. A DEVICE HISTORY RECORD COULD NOT BE COMPLETED AS NO LOT NUMBER WAS RECEIVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PILOT BALLOON AND INFLATION LINE WERE BROKEN. THE EVENT OCCURRED DURING INFUSION AT THE FACILITY. THERE WAS PATIENT INVOLVEMENT, BUT NO HARM/ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1206988 PORTEX BLUE LINE ULTRA SUCTIONAID CUFFED TRACHEOSTOMY TUBE TUBE, TRACHEOSTOMY (W/WO CONNECTOR) BTO SMITHS MEDICAL CZECH REPUBLIC A. S UNKNOWN 15019517076158

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown