BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX BLUSELECT SUNCTIONAID CUFFED TRACHEOSTOMY TUBE

    MDR report key: 19714036 · Received July 10, 2024

    Report

    Report Number
    3011237704-2024-00137
    Event Type
    Malfunction
    Date Received
    July 10, 2024
    Date of Event
    June 1, 2024
    Report Date
    August 2, 2024
    Manufacturer
    SMITHS MEDICAL CZECH REPUBLIC A. S
    Product Code
    BTO
    UDI-DI
    15019517076172
    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

    B3. DATE OF EVENT: MONTH AND YEAR OF EVENT HAVE BEEN PROVIDED, BUT DAY IS UNKNOWN. E1. INITIAL REPORTER LAST NAME UNKNOWN. E1 - INITIAL REPORTER EMAIL UNKNOWN. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: ONE USED DECONTAMINATED 10009163-006 9.0MM DEHT BLU SUCTIONAID SUB-ASSY WAS RETURNED FOR INVESTIGATION. UNDER VISUAL INSPECTION WE NOTICED THAT INFLATION LINE WAS DETACHED FROM PILOT BALLOON. WITHOUT MORE DETAILED INFORMATION WE ARE UNABLE TO DETERMINE WHAT HAD HAPPENED BECAUSE NO DETACHMENT IS MENTIONED. THE CUSTOMER'S INDICATED FAILURE OF "AIR LEAK" WAS CONFIRMED, BUT THE ROOT CAUSE COULD NOT BE DETERMINED. 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 AIR LEAKED FROM THE DEVICE. THERE WAS NO DISINFECTION OR STERILIZATION, AND NO INFECTIOUS DISEASE OCCURRED. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2165017 PORTEX BLUSELECT SUNCTIONAID CUFFED TRACHEOSTOMY TUBE TUBE, TRACHEOSTOMY (W/WO CONNECTOR) BTO SMITHS MEDICAL CZECH REPUBLIC A. S NI 15019517076172

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown