BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX BLUSELECT SUCTIONAID CUFFED TRACHEOSTOMY

    MDR report key: 20868105 · Received December 6, 2024

    Report

    Report Number
    3011237704-2024-00272
    Event Type
    Malfunction
    Date Received
    December 6, 2024
    Date of Event
    November 5, 2024
    Report Date
    April 21, 2025
    Manufacturer
    SMITHS MEDICAL CZECH REPUBLIC A. S
    Product Code
    BTO
    UDI-DI
    15019517076233
    PMA / PMN Number
    K173384
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D1 - BRAND NAME, D3, D4 - EXPIRATION DATE AND D4 - PRIMARY UDI NUMBER: CORRECTED. H6: UPDATED. H3: ONE SAMPLE WAS RETURNED FOR EVALUATION. SAMPLE WAS VISUALLY AND FUNCTIONALLY TESTED AND IT WAS FOUND THAT IT WAS NOT POSSIBLE TO INFLATE THE CUFF BECAUSE THE AIR DOES NOT FLOW FROM THE BALLOON PILOT INTO THE CUFF. THE CUSTOMER REPORTED COMPLAINT WAS ABLE TO BE CONFIRMED. THE ROOT CAUSE OF THE ISSUE IS UNKNOWN. A REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THERE WERE NO OBSERVATIONS RECORDED DURING MANUFACTURE TO SUGGEST AN ISSUE OF THIS NATURE WOULD OCCUR WITH THIS LOT OF PRODUCT. THERE WERE NOT ANY OTHER CUSTOMER COMPLAINTS AGAINST THE REPORTED LOT NUMBER.

    Additional Manufacturer Narrative · 0

    H3. REASON DEVICE NOT EVALUATED BY MFG: OTHER; DEVICE WAS NOT RETURNED TO MANUFACTURER. 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 STATED THAT THE BLUE BALLOON DEFLATED, AND THE CAP CAME OFF WHILE THE DEVICE WAS USED ON PATIENT. THERE WAS UNKNOWN PATIENT INVOLVEMENT. PATIENT WAS A MALE WHO WEIGHTS 62 KG. HE WAS NOT PRESCRIBED ANY MEDICAL TREATMENT. THE PATIENT WAS REPORTED TO TAKE MEDICATIONS CONCOMITANTLY VIA GPE (PERCUTANEOUS ENDOSCOPIC GASTROSTOMY). THE EVENT WAS RESOLVED AFTER CHANGING THE CANNULA. THERE WAS PATIENT INVOLVEMENT, BUT NO CLINICAL CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2094915 PORTEX BLUSELECT SUCTIONAID CUFFED TRACHEOSTOMY TUBE, TRACHEOSTOMY (W/WO CONNECTOR) BTO SMITHS MEDICAL CZECH REPUBLIC A. S 4458549 15019517076233

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male MEDICATIONS.