BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX BLUSELECT DILATION TRACHESTOMY KIT

    MDR report key: 15043281 · Received July 18, 2022

    Report

    Report Number
    3012307300-2022-13528
    Event Type
    Malfunction
    Date Received
    July 18, 2022
    Report Date
    October 16, 2023
    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 CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    4582; A1203 [1171]; B21 [4118]; C21 [3233]; D16 [11].

    Additional Manufacturer Narrative · 0

    ONE USED DECONTAMINATED DEVICE WAS RECEIVED FOR INVESTIGATION WITHOUT ITS ORIGINAL PACKAGING. UNDER VISUAL INSPECTION IT WAS NOTICED THE SUCTION LINE CONNECTOR WAS PARTIALLY DETACHED. THE COMPLAINT WAS CONFIRMED. THE ROOT CAUSE WAS DUE TO THE TUBE NOT SUBMERGED PROPERLY IN SOLVENT DISPENSER OR DISPENSER WITH LOW LEVEL OF SOLVENT DURING MANUFACTURING. NO LOT NUMBER WAS PROVIDED SO A DEVICE HISTORY RECORD (DHR) REVIEW AND SERVICE HISTORY COULD NOT BE PERFORMED. AWARENESS WAS MADE TO OPERATION PERSONNEL AND THE ISSUE WILL BE MONITORED FOR THRESHOLD OR ESCALATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE USE OF THE PRODUCT, THE SUCTION LINE CAME OFF. AS AN EMERGENCY MEASURE, THE PRODUCT WAS FIXED WITH MEDICAL TAPE AND CONTINUED TO BE USED UNTIL THE TIME WHEN IT WOULD BE REPLACED WITH NEXT ONE. NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398861 PORTEX BLUSELECT DILATION TRACHESTOMY KIT TUBE, TRACHEOSTOMY (W/WO CONNECTOR) BTO SMITHS MEDICAL INTERNATIONAL, LTD. 101/860/080CZ 15019517076158

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown