BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX PERCUTANEOUS KIT WITH BLUSELECT TRACH TUBE

    MDR report key: 20292476 · Received September 24, 2024

    Report

    Report Number
    3011237704-2024-00195
    Event Type
    Malfunction
    Date Received
    September 24, 2024
    Date of Event
    September 4, 2024
    Report Date
    November 26, 2024
    Manufacturer
    SMITHS MEDICAL CZECH REPUBLIC A. S
    Product Code
    BTO
    UDI-DI
    15019517103342
    PMA / PMN Number
    K173912
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3 AND H6. CODES: UPDATED. ONE DEVICE SAMPLE, NO FORCEPS WAS RECEIVED FOR INVESTIGATION. UNDER VISUAL INSPECTION IT WAS CONFIRMED THAT THERE IS A LABEL ON THE SHELF CARTON WITH ITEM NUMBER 101/561/080 WITH LOT 4382035. THE INNER PACKAGING CONTAINS A DIFFERENT PRODUCT WITH ITEM NUMBER 101/543/080 AND LOT NUMBER 4382017. THE COMPLAINT ISSUE HAS BEEN ESCALATED AND CORRECTIVE ACTIONS ARE IN PROCESS. A DEVICE HISTORY RECORD (DHR) REVIEW REPORTED NO DISCREPANCIES OR NON-CONFORMANCES DURING THE MANUFACTURING OF THE REPORTED LOT NUMBER.

    Additional Manufacturer Narrative · 0

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE OUTER PACKAGING BOX OF THE PRODUCT THEY RECEIVED HAD A DIFFERENT LOT AND LIST NUMBER FROM THE INNER PACKAGING. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2104151 PORTEX PERCUTANEOUS KIT WITH BLUSELECT TRACH TUBE TUBE, TRACHEOSTOMY (W/WO CONNECTOR) BTO SMITHS MEDICAL CZECH REPUBLIC A. S 4382017 15019517103342

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown